MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK PRIORITY CUST IMPL LARGE; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number	78-50030
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	03/12/2025
Type of Reportable Event	Malfunction
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 the implant required major adjustment due to soft tissue interference.This caused a delay of 50 minutes.
Additional Manufacturer Narrative
Additional information: d6a, h4, h6 correction: d2a the reported event could not be confirmed.As no images or ct scans were provided.Peek study 2023 assessed implant placement and fit for subject (b)(6) and the surgeon required 50 minutes of adjustment due to soft tissue interference.Device records confirmed compliance with specifications and no device 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 PRIORITY CUST IMPL LARGE
• 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 ; +49 7614888208
• MDR Report Key: 23680820
• Report Number: 0008010177-2025-00161
• Device Sequence Number: 15948561
• Product Code: GWO
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 78-50030
• Device Lot Number: 2502071012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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