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

Catalog Number	78-40020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a new implant is needed due to repeated infection.
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: h6.Correction: it was determined after receiving further clarification from the customer and the log files from the device, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.The patient received a peek implant in (b)(6) 2024 due to repeated infection after prior surgeries.Medical expert and surgeon concluded the infection was clinically related and not caused by the implant (see communication log).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, M
• 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: 23827565
• Report Number: 0008010177-2025-00166
• Device Sequence Number: 5093801
• Product Code: GWO
• UDI-Device Identifier: 07613327129335
• UDI-Public: 07613327129335
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 78-40020
• Device Lot Number: 2312151015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown