BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FINGER IMPLANT - SIZE 4

    MDR report key: 23729737 · Received December 5, 2025

    Report

    Report Number
    3008395366-2025-00316
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    OSTEOTEC LIMITED
    Product Code
    KYJ
    UDI-DI
    05060183090057
    PMA / PMN Number
    K140453
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SALES MANAGER REPORTED ON 05NOV2025 THAT AN OSTF-4 HAD TO BE REMOVED DUE TO THE IMPLANT BREAKING. IT WAS STATED THAT THE INITIAL CASE TOOK PLACE ON (B)(6) 2025 BUT NEEDED REVISION SURGERY ON (B)(6) 2025. THE SURGEON ULTIMATELY IMPLANTED A SECOND OSTF-4 WITH NO ISSUE. THE SURGEON WAS NOT UPSET ABOUT THE IMPLANT AND TRIED TO COLLECT INFORMATION IF THE PATIENT FELL OR WHAT HAPPENED, HOWEVER, THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE PATIENT. A PHOTOGRAPH OF THE FRACTURED IMPLANT WAS PROVIDED, AND THE DEVICE HAS BEEN MADE AVAILABLE FOR RETURN AND EVALUATION. AT THIS STAGE, NO FURTHER INVESTIGATION OR FAILURE ANALYSIS DETAILS ARE AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL MDR IF RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867465 SILICONE FINGER IMPLANT - SIZE 4 OSTF-4 KYJ OSTEOTEC LIMITED OSTF-4 121912 05060183090057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention