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

Catalog Number	54440610
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	10/01/2025
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 the superior extent of the implant was too close to the lower incisors and required burring intraoperatively to relieve it enough to close.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6.Correction: d3, g1.The reported event could not be confirmed as no images were provided for review.Further information from the sales rep confirmed the procedure was completed successfully with no adverse consequences, and only minor contouring of the implant was performed.Stryker r&d reviewed the case and verified that the design followed all procedures, with documentation showing the surgeon had confirmed and verbally approved the implant perimeter and contours during the design call.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.

• Brand Name: MEDPOR CUSTOMIZED-MANDIBLE
• 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: 23378628
• Report Number: 0008010177-2025-00140
• Device Sequence Number: 13061930
• Product Code: FWP
• UDI-Device Identifier: 07613252457671
• UDI-Public: 07613252457671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/28/2026

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: 54440610
• Device Lot Number: 2503191057
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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