BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOTEC

    MDR report key: 23877773 · Received December 23, 2025

    Report

    Report Number
    3008395366-2025-00869
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    May 2, 2023
    Report Date
    December 23, 2025
    Manufacturer
    OSTEOTEC LIMITED
    Product Code
    KYJ
    PMA / PMN Number
    K140453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    505

    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 A COMBINATION OF INADEQUATE BONE SURFACE PREPARATION WITH SHARP AREAS ADJACENT TO THE IMPLANT SITE AND DAMAGE TO THE IMPLANT FROM FORCEPS, 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, AND ALSO SURGEONS "ATRAUMATIC FORCEPS SHOULD BE USED TO AVOID DAMAGING THE IMPLANT" TO ENSURE CORRECT FORCEPS ARE USED. DUE TO EXPLANTED DEVICE NOT BEING RETURNED, IT WAS NOT POSSIBLE TO CONDUCT A FULL INVESTIGATION. HAVING REVIEWED THE HISTORICAL RECORDS FOR THIS DEVICE, THERE ARE NO TRENDS THAT INDICATE THE DEVICE OR LOT HAVE ANY UNUSUAL CHARACTERISTICS. COMPLAINT TRENDING ACROSS THE OSTF PRODUCT FAMILY IDENTIFIED TWO OTHER FRACTURE COMPLAINTS ASSOCIATED WITH THE SAME 2021 MANUFACTURING ORDER; HOWEVER, NO SYSTEMIC MANUFACTURING, MATERIAL, OR DESIGN ISSUE WAS IDENTIFIED. NO NEW RISKS WERE IDENTIFIED, AND NO FURTHER REMEDIAL ACTIONS ARE REQUIRED AT THIS TIME. WE WILL CONTINUE ROUTINE POST-MARKET SURVEILLANCE AND TRENDING.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING FRACTURE OF THE SILICONE FINGER IMPLANT LESS THAN 2 MONTHS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918673 OSTEOTEC OSTEOTEC SILICONE FINGER IMPLANT KYJ OSTEOTEC LIMITED OSTF-3 121909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention