MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUST. CRANIAL IMPL. LARGE; IMPLANT

Catalog Number	78-10030
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	08/22/2025
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 did not fit the patient properly and impinged inferiorly.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: d6a, d9, h3, h4, h6 device evaluation: follow-up report submitted to document device evaluation results.The reported event that just a part of the implant together with a mesh was implanted could be confirmed, as the remaining part of the implant was sent back to stryker freiburg and post-op scans were provided.The complaint analysis confirmed that the peek implant and bone model were designed and manufactured according to specifications; however, fitting issues were likely caused by remaining calcifications and the anatomically challenging temporal area.The surgeon modified the implant intraoperatively and used a mesh to cover part of the defect, resulting in a 30-minute surgical delay but no adverse effects or need for additional surgery.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 CUST. CRANIAL IMPL. LARGE
• 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: 22937066
• Report Number: 0008010177-2025-00103
• Device Sequence Number: 21277978
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/23/2025

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: 78-10030
• Device Lot Number: 2507211027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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