MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUST. CRANIAL IMPL MEDIUM; IMPLANT

Catalog Number	78-10020
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	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant required moderate adjustment due to changes of anatomy.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: h4, h6.The reported event could not be confirmed as no images or ct-scans were provided.The surgeon identified anatomical changes and calcifications as contributing factors, with no concerns regarding the implant design.Stryker¿s analysis confirmed the implant was manufactured per specifications and noted that anatomical variability, particularly in a tight and uneven area later included per the surgeon¿s request, likely contributed to the fit issue; minor trimming during surgery is not uncommon, and no device-related problem was found.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: PEEK CUST. CRANIAL IMPL MEDIUM
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21704468
• Report Number: 0008010177-2025-00035
• Device Sequence Number: 9952201
• Product Code: GWO
• UDI-Device Identifier: 07613327004021
• UDI-Public: 07613327004021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/21/2025

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 Catalogue Number: 78-10020
• Device Lot Number: 2408221044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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