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

Catalog Number	5444-4-310
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
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 the surgeon had problems with the implant fitment and ended up having to use ti mesh.
Event or Problem Description
It was reported, that the surgeon had problems with the implant fitment and ended up having to use ti mesh.
Additional Manufacturer Narrative
Correction: b1.Added: h6.The reported issue that a customized implant did not fit properly and had gaps after trimming could not be confirmed due to a lack of supporting evidence (e.G., post-op images or scans).According to the sales representative, the implant caused a 45-minute surgical delay due to fitting difficulties.The surgeon attempted to trim the implant but was left with gaps, which were covered using titanium mesh.No revision surgery is planned.A design analysis found no deviations from the standard process.The designer noted that gaps could occur depending on where trimming was done, particularly given the flanged design of the implant.A device history record (dhr) review by the manufacturing site (stryker mahwah) also revealed no deviations or discrepancies.In conclusion, the root cause of the issue could not be determined.There is no evidence of design, material, or manufacturing defects.Therefore, no corrective or preventive actions are necessary, and the complaint has been added to the trend analysis.

• Brand Name: MEDPOR PRIORITY CUSTOMIZED CRANIAL - L
• 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: 20564745
• Report Number: 0008010177-2024-00118
• Device Sequence Number: 7988860
• Product Code: FWP
• UDI-Device Identifier: 07613327466454
• UDI-Public: 07613327466454
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K191916
• 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): 05/21/2025

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: 5444-4-310
• Device Lot Number: 2409301040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 05/21/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown