MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, XL; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number	78-40040
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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 within the hospital two peek implants were mixed up.The procedure was successfully completed with the correct peek implant with a surgical prolongation of more than 120 min.
Additional Manufacturer Narrative
Additional information: d6a, h4, h6.Corrected data: d2a.The reported event could be confirmed.Two peek implants were mixed up at the hospital due to a user related issue, resulting in a prolonged surgery; both implants were manufactured per specifications, resterilization followed the 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.
Event or Problem Description
No new information.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, XL
• 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23554098
• Report Number: 0008010177-2025-00157
• Device Sequence Number: 10160284
• Product Code: GWO
• UDI-Device Identifier: 07613327129250
• UDI-Public: 07613327129250
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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?: No
• Device Catalogue Number: 78-40040
• Device Lot Number: 2509161031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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