MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, S; Plate, cranioplasty, preformed, alterable

Catalog Number	78-40010
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was unable to navigate the graft in the application because the navigation points were not marked.Nevertheless, the product was implanted successfully, and the surgical procedure was completed without complications.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, S
• Common Device Name: Plate, cranioplasty, preformed, alterable
• 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 gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24265766
• Report Number: 0008010177-2026-00007
• Device Sequence Number: 10022391
• Product Code: GWO
• UDI-Device Identifier: 07613327129236
• UDI-Public: 07613327129236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: 78-40010
• Device Lot Number: 2511241012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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: Other
• Patient Sex: Unknown