MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUS. CRANIAL IMPL SMALL; IMPLANT

Catalog Number	78-10010
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant required slight adjustment due to change of anatomy/calcifications.
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
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6.The reported event could not be confirmed, as no images or ct-scans were provided.The surgeon attributed the issue to anatomical changes and calcifications, with no concerns about implant design; although no postoperative images were provided, the sales representative reported proper implant fit, no brain swelling or surgeon dissatisfaction, and noted tissue buildup that was adjusted during a successful surgery.Device history records confirmed the peek implant met specifications and allowed modifications per ifu, and no device-related problem was identified.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.

• Brand Name: PEEK CUS. CRANIAL IMPL SMALL
• 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: 23030897
• Report Number: 0008010177-2025-00110
• Device Sequence Number: 9820538
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• 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): 01/21/2026

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: 78-10010
• Device Lot Number: 2507021080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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