MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, M

Catalog Number	78-40020
Medical Device Problem Codes	Accessory Incompatible (1004); Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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
This event concerns a peek single-stage procedure.As provided dicom data turned out to be incompatible with brainlab dicom images needed to be re-exported.The procedure was completed successfully and no medical intervention, surgical delay or any adverse consequences were reported.
Additional Manufacturer Narrative
The reported event was confirmed based on the analysis of the dicom data provided.A compatibility issue occurred when navigation data created with one software version could not be used with the surgeon's navigation system during surgery, even though the data complied with international standards.The problem was solved by using an older software version.Alternative methods of transferring surgical plans - such as manual measurements or a marking aid - are available and recommended if compatibility cannot be confirmed prior to surgery.Based on the investigation steps performed, no product issue has been identified that indicates nonconformity, an unfavorable trend or an unexpected hazard/harm.Therefore, no corrective action is required at this time.Product surveillance will continue to monitor complaints of this nature for adverse trends.
Event or Problem Description
No new information.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, M
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 20913924
• Report Number: 0008010177-2024-00139
• Device Sequence Number: 20948857
• Product Code: GWO
• UDI-Device Identifier: 07613327129335
• UDI-Public: 07613327129335
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 78-40020
• Device Lot Number: 2409261009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 06/05/2025
• 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
• Patient Sex: Unknown