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

Catalog Number	54440410
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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
It was reported that after placing the implant during surgery, a gap was noticed.
Additional Manufacturer Narrative
Additional information: h4, h6.Correction: d3, g1.The reported event that the customized implant did not fit initially could be confirmed based on the intraoperative pictures provided.The reported event involved a surgical delay of 10¿30 minutes due to implant fitting issues, which were resolved through intraoperative modification; postoperative ct scans were not provided, though some intraoperative images were shared.A full review, including design, manufacturing, and device history, revealed no process deviations, with the outdated ct scan used for planning identified as a potential contributing factor, but the root cause could not be definitively determined.Based on the investigation, the assessment of the designer and the dhr review, 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 CUSTOMIZED CRANIAL-XL
• 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: 21157820
• Report Number: 0008010177-2025-00003
• Device Sequence Number: 15561692
• Product Code: FWP
• UDI-Device Identifier: 07613252457664
• UDI-Public: 07613252457664
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/12/2025

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: 54440410
• Device Lot Number: 2409261063
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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