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	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: h4, h6 the reported event could not be confirmed as images or post op ct scans were not provided by the customer for review.Additional review determined the procedure was completed with a brief delay to remove bone fragments and calcifications, with no adverse outcomes, and ct images used for design already showed brain swelling, which may have contributed to the reported rocking effect noted in the ifu and design documentation.Reviews by stryker r&d and manufacturing found the design, data transfer, and manufacturing fully compliant with all requirements, no deviations in testing, and ultimately the root cause of the event could not be determined.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.
Event or Problem Description
It was reported that one side of the implant was lifting when pressure was applied to one side, the opposite side would rise.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.

• 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: 23199526
• Report Number: 0008010177-2025-00121
• Device Sequence Number: 21116926
• 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): 01/21/2026

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: 2508131048
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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