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

Catalog Number	78-10040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	01/27/2023
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 slight adjustment due to soft tissue interference.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6.The reported event could not be confirmed, as there were no images or ct-scans provided.The surgeon identified soft tissue interference as a contributing factor but reported no issues with the implant design.A cerebrospinal fluid (csf) collection occurred post-procedure, requiring medical intervention, which the surgeon attributed to the procedure rather than the device, and overall expressed satisfaction with the implants used in the study; device records confirm the implant was manufactured per specifications with no device-related problems found.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 XLARGE
• 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: 21896191
• Report Number: 0008010177-2025-00052
• Device Sequence Number: 3442424
• Product Code: GWO
• UDI-Device Identifier: 04546540730794
• UDI-Public: 04546540730794
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 78-10040
• Device Lot Number: 2211291039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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