MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-8PLATES; IMPLANT

Model Number	78-92008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had broken facial id plates removed and replaced.There were no adverse consequences reported.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.Device not available.
Additional Manufacturer Narrative
The reported event could be confirmed: the returned plates show fractures.Three plates of the set under complaint were returned in order to determine the root cause of the failure.The samples were examined regarding its dimensions, chemical composition (edx analysis) and by light and scanning electron microscopy.The (measurable) dimensions are in accordance with the specification.The chemical composition of all three plates conform to the specification titanium grade 3.The macroscopic appearances of all three plates point to exceeding the material strength.That is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structure, and the secondary cracks in the area of the breakages.The fracture surfaces were partially and / or totally leveled due to friction with the counterpart.The undestroyed fracture surfaces (rest) show the appearance of a low cycle fatigue rupture.The fractographic investigations with sem show a structure of a low cycle fatigue rupture with secondary cracks and in addition, swinging lines of a fatigue breakages are visible.The further provided information did not show any deviation from the user¿s instructions.All relevant quality documents (manufacturing and inspection documents) have been reviewed.The device history records for catalog # 78-92008 and lot code # 2008141014 indicate (b)(4) was manufactured, accepted into final stock on 2020-aug-28.No issues could be found in the manufacturing or inspection documents.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 corrective and / or preventive actions are deemed necessary at this time.
Event or Problem Description
It was reported that the patient had broken facial id plates removed and replaced.There were no adverse consequences reported.

• Brand Name: FACIAL ID-ORTHOG-8PLATES
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13052590
• Report Number: 0008010177-2021-00056
• Device Sequence Number: 4153400
• Product Code: JEY
• UDI-Device Identifier: 07613327370881
• UDI-Public: 07613327370881
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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
• Device Model Number: 78-92008
• Device Catalogue Number: 78-92008
• Device Lot Number: 200814101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown