Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.

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.

Data reported in patient medical charts

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)).

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.

Diagnosis collected from patient medical charts.

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

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

Underlying medical conditions and medication that may be related to the device or primary outcome.

Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; Le Fort I; Le Fort II; Le Fort III; others

For patients that receive maxillo-mandibular fixation post operation the length of time after surgery the fixation procedure took place (days).

Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts (number and type of radiation procedures performed).

Radiation therapy performed on the anatomical area treated with the device.

Any postoperative radiation therapy recorded in patient medical charts.

Sterilization method used for the device. Qualitative responses from site.

System used to fix the device during the procedure. Stryker Universal CMF screws; others

Tools used to fix the device during the procedure. Response options include :

Manual and electric screw driver

Usage of splints in orthognathic cases.

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)

Weight (kg, lb)

Height (cm, feet, inches)

Age (years)

Responses: Male, Female, undifferentiated, unknown