Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up

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.

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 adverse events reported from patient medical charts.

Time patients are operated (hh:mm)

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

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

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

Short-form-12-health-survey-Questionnaire (Scale of 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health).

Ischemia time (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)).

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.

Age (years)

Diagnosis collected from patient medical charts.

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

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

Cases where osteotomy (e.g. BSSO) was performed. Instrumentation used to perform the osteotomy.

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

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

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

Responses: Male, Female, undifferentiated, unknown

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)