MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MEDPOR CUSTOMIZED CRANIAL-S; PROSTHESIS, CHIN, INTERNAL

Catalog Number	54440110
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/20/2026
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 patient developed an infection after the initial surgery that leaked from their eye.During the investigation of the infection, part of the implant had to be removed.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.Correction: d2a.It was determined after receiving further clarification, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.The reported infection and subsequent partial implant removal were investigated.Review of sterilization records, environmental monitoring data, and packaging controls identified no deviations.Medical assessment concluded that the device did not cause or contribute to the reported infection.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 CRANIAL-S
• Common Device Name: PROSTHESIS, CHIN, INTERNAL
• 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 gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24638120
• Report Number: 0008010177-2026-00036
• Device Sequence Number: 9786503
• Product Code: FWP
• UDI-Device Identifier: 07613252457626
• UDI-Public: 07613252457626
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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?: No
• Device Catalogue Number: 54440110
• Device Lot Number: 2512311003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 09/15/2026
• 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: Required Intervention
• Patient Sex: Unknown