BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOTEC

    MDR report key: 23876048 · Received December 23, 2025

    Report

    Report Number
    3008395366-2025-00493
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    July 12, 2019
    Report Date
    December 23, 2025
    Manufacturer
    OSTEOTEC LIMITED
    Product Code
    KYJ
    PMA / PMN Number
    K140453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OSTEOTEC HAS DETERMINED THAT HISTORICAL COMPLAINTS RELATING TO THE OSTEOTEC SILICONE FINGER IMPLANT SHOULD HAVE BEEN REPORTED AS AN MDR EVENT. WHILE SUBMITTING THIS REPORT AS A PRECAUTIONARY MEASURE, OSTEOTEC BELIEVES THE INCIDENT STEMMED FROM INADEQUATE BONE SURFACE PREPARATION WITH SHARP AREAS ADJACENT TO THE IMPLANT SITE, NOT A MATERIAL DEFECT IN THE MEDICAL GRADE SILICONE IMPLANT ITSELF. THE SURGICAL TECHNIQUE ADVISES SURGEONS TO "USE FINE BURR TO REMOVE OSTEOPHYTES AND SHARP EDGES THAT COULD DAMAGE THE IMPLANT" HIGHLIGHTING THE IMPORTANCE OF PROPER SITE PREPARATION. DUE TO THE DELAY BETWEEN EXPLANT AND BEING MADE AWARE OF THE COMPLAINT, IT WAS NOT POSSIBLE TO RECOVER THE EXPLANTED DEVICE FOR FULL INVESTIGATION. HAVING REVIEWED THE HISTORICAL RECORDS FOR THIS DEVICE, THERE ARE NO TRENDS THAT INDICATE THE DEVICE OR LOT HAVE ANY UNUSUAL CHARACTERISTICS.

    Description of Event or Problem · 0

    DR. (B)(6) REMOVED A BROKEN SILICONE FINGER IMPLANT FROM A PATIENT ROUGHLY 6 MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828766 OSTEOTEC OSTEOTEC SILICONE FINGER IMPLANT KYJ OSTEOTEC LIMITED OSTF-4 110315

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other