MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDPOR PRIORITY CUSTOMIZED CRANIAL - L; IMPLANT

Catalog Number	5444-4-310
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	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the medpor implant mismatched and needed to be shaved around to reduce the rigidity.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: h4, h6.The reported event that the customized implant did not fit initially could be confirmed, based on the comparison of the post operative ct scan and the ct scan of the planning.However, the root cause could not be determined.The sales representative reported a surgical delay of about 20 minutes related to the implant, and postoperative ct scans were provided for analysis.A design and dhr review found no deviations or discrepancies in the design, quality, or manufacturing processes, with all required tests completed and passed successfully.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.
Event or Problem Description
No new information.

• Brand Name: MEDPOR PRIORITY CUSTOMIZED CRANIAL - L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 22738566
• Report Number: 0008010177-2025-00098
• Device Sequence Number: 7198345
• Product Code: FWP
• UDI-Device Identifier: 07613327466454
• UDI-Public: 07613327466454
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 10/31/2025

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: 2506191059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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