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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
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 that it was discovered during a post-op scan, that the facial id plate had broken.There is no other information known at this time.
Event or Problem Description
It was reported that it was discovered during a post-op scan, that the facial id plate had broken.There is no other information known at this time.
Additional Manufacturer Narrative
The reported event could be confirmed as the returned plate shows fractures.The (measurable) dimensions are in accordance with the specification.The chemical composition of the plate conforms to the specification titanium grade 3.The macroscopic appearances of the plate 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 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.It was further reported that the patient believes she heard the plate has snapped few weeks before the plate was removed.Furthermore, the patient was having significant pain as a result of the broken plate.As the surgeon removed the plate, it was determined that the bone has never healed, so a l-plate was implanted.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any design, material or manufacturing related issue.

• 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
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 15053522
• Report Number: 0008010177-2022-00023
• Device Sequence Number: 5213434
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 78-92002
• Device Catalogue Number: 78-92002
• Device Lot Number: 2103301050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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