MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK PRIORITY CUST IMPL LARGE; IMPLANT

Catalog Number	78-50030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
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 during surgery, it was found that the implant did not fit as expected.The surgeon had to cut the implant to have it fit.
Event or Problem Description
It was reported that during surgery, it was found that the implant did not fit as expected.The surgeon had to cut the implant to have it fit.
Additional Manufacturer Narrative
Update: h6 the event is confirmed by the sales representative, despite no objective evidence from ct scans or photos.The sales rep reported brain swelling but no anatomical changes, stating that the implant was proud at the back, necessitating the surgeon to cut it in half for fitting.A complaint analysis by stryker's custom design team found that the implant design met specifications.The pre-op scan, conducted on (b)(6) 2024, showed that the implant transitioned seamlessly to the bone, and the contour was symmetric to the contralateral side.However, significant brain swelling noted in the planning ct scan created a "rocking effect," making the implant appear protruded.Additionally, insufficient temporal clearance (1.5 mm) may have contributed to fitting challenges.No postoperative imaging or intraoperative photos are available for further evaluation, preventing a definitive root cause determination.A surgical delay of 30-45 minutes was reported.In conclusion, the peek implant was designed and manufactured according to specifications, and no device-related issues were identified.Therefore, no corrective actions are required, and the complaint will be monitored for trends.

• Brand Name: PEEK PRIORITY CUST IMPL LARGE
• 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 ; 7614888208
• MDR Report Key: 19569365
• Report Number: 0008010177-2024-00053
• Device Sequence Number: 12506126
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 78-50030
• Device Lot Number: 2405131067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown