Facial iD Customized Mandible Reconstruction Plates

Rate of unplanned revision surgery determined by reviewing adverse events in patient medical charts after surgery. Used to document whether an unplanned revision surgery was required or not for each patient.

Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment.

Determined by adverse events reported from patient medical charts.

Determined by adverse events reported from patient medical charts.

Determined by adverse events reported from patient medical charts.

Determined by adverse events reported from patient medical charts.

Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture.

Time patients are operated (dd:hh)

Time for patient to return to solid food/normal diet post operation (dd)

Time the patient was hospitalized post procedure (dd:hh)

A descriptive system and a visual analogue scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three to five levels of severity. The VAS provides a subjective rating of overall health on a scale from 0 to 100 (higher is better)).

Questionnaire only for medically trained professionals on site staff using the device. Questions relate to subjective rating of ease of use by the surgeon if compared to stock plates (evaluated per treating surgeon, not per patient). Questionnaire is qualitative response regarding the ease of use of the device.

Fit of implant Time for adaptations

40 independently functioning scales and checklists. Multiple independent scales, each with a 0-100 score, where higher scores indicate better outcomes. Scores are calculated by summing responses on a 4-point Likert scale (e.g., strongly disagree to strongly agree), which are then converted to the 0-100 range. Each scale measures a specific aspect of facial appearance, quality of life, or adverse effects and cannot be summed into a single total score.

12 items grouped and scored to produce two separate summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). The scale is transformed to a 0-100 range with higher scores indicating better health.

The visual analogue scale (VAS) is a psychometric response scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

Ischemia time (dd:hh)

Number of maxillo-mandibular fixation procedures (number per patient).

Post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visits.

Type of flap used: vascularized fibula flap, vascularized scapula flap, vascularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others

Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts.

Radiation therapy performed on the anatomical area treated with the device. Any postoperative radiation therapy recorded in patient medical charts.

Data for dental reconstruction collected from patient medical charts.

Sterilization method used for the device.

System used to fix the device during the procedure. Stryker Universal Mandible System; other

Types and number of screws

2.0 or 2.8 plates used Hemi or full reconstruction plate used

Age (years)

Responses: Male, Female, undifferentiated, unknown

Diagnosis collected from patient medical charts.

Surgical approach taken for the procedure. Including: transoral; transbuccal; submandibular; preauricular; other

Descriptive data of any underlying medical conditions and medications recorded in patient medical charts that may be related to the device or primary outcome (qualitative measure).

Type of reconstruction procedure performed (e.g. immediately or after an initial surgery).

Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other

Height (cm, feet, inches)

Weight (kg, lb)

Year smoking was stopped (YYYY)

The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).

Duration of smoking (pack years)

Total number of years active smoker (YY)