MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR CUSTOMIZED CRANIAL-XL; IMPLANT

Catalog Number	54440410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
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 a patient a second infection.Device was removed.
Additional Manufacturer Narrative
Update: h6.Due to the nature of the complaint, the observation described in the reported event could not be confirmed.Expanded investigations found no manufacturing or process-related issues contributing to the infection complaint.According to the r&d medpor expert, infections are typically caused by contamination during surgery or by later exposure.This statement, originally made during the investigation of a previous complaint, was confirmed by a stryker healthcare professional.Based on all available information, the root cause of this complaint could not be determined.The investigation revealed no indication of any systematic design, material, or manufacturing-related issues.Therefore, no corrective or preventive actions are deemed necessary at this time.The complaint has been added to the complaint trend.
Event or Problem Description
No new information.

• Brand Name: MEDPOR CUSTOMIZED CRANIAL-XL
• 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: 20283805
• Report Number: 0008010177-2024-00101
• Device Sequence Number: 8012938
• Product Code: FWP
• UDI-Device Identifier: 07613252457664
• UDI-Public: 07613252457664
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K143173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 54440410
• Device Lot Number: 2404101047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 06/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown