MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-2PLATES; IMPLANT

Model Number	78-92002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by the company representative that a broken plate and infection was discovered post operatively, and a revision surgery was performed to have plate removed.The customer believes the stryker product did not cause the infection but rather, a wound infection.No other information is known at this time.
Additional Manufacturer Narrative
The reported event could not be confirmed as there was no product return and no pictures that illustrate the breakages were sent for evaluation however, further information was provided that the plates were not re-bent at any time.The complaint analysis document provided by the stryker design engineer, as well as device history records verify that all the processing steps were performed according to specification.The plate was perfect for both plates.Furthermore, the plate design was nice and simple.All requirements were met (screw system 1.7 allowed for midface, profile height was 1.0mm which is more stable that the allowed 0.8mm, two screw holes on each native bone piece were present).Related to the event in question, a review of additional documentation (x-rays) was performed.The x-rays provided were forwarded to stryker¿s senior global medical director along with the complaint information.In sum, the root cause for the breakage of the plate cannot be determined.According to the related design risk analysis, a possible root cause for the reported breakage is: -inappropriate tools, technique and/ or screws used for plate fixation.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.H3 other text : device not available for return.
Event or Problem Description
It was reported by the company representative that a broken plate and infection was discovered post operatively, and a revision surgery was performed to have plate removed.The customer believes the stryker product did not cause the infection but rather, a wound infection.No other information is known at this time.

• Brand Name: FACIAL ID-ORTHOG-2PLATES
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10561138
• Report Number: 0008010177-2020-00052
• Device Sequence Number: 1241012
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 78-92002
• Device Catalogue Number: 78-92002
• Device Lot Number: 1910071006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1