BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE PIP SZ. 1

    MDR report key: 8875563 · Received August 8, 2019

    Report

    Report Number
    1651501-2019-00029
    Event Type
    Injury
    Date Received
    August 8, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR - REVIEW OF MANUFACTURING RECORDS FOR SPIP-520-1-WW CMR 163711T SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FAILURE ANALYSIS - THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO DATE. IMAGES OF THE EXPLANTED SPIP WERE PROVIDED SHOWING THE DEVICE IN TWO PIECES, SEPARATED AT THE HINGE, CONFIRMING THE REPORTED EVENT. ROOT CAUSE - BASED ON THE INFORMATION RECEIVED TO DATE, THE ROOT CAUSE IS UNDETERMINED. THE EVENT MAY BE DUE TO TRAUMA OR AN IMPROPERLY SEATED IMPLANT LEADING TO ADDITIONAL STRESS ON THE HINGE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A SILICONE PIP (ID SPIP-520-1-WW - SILICONE PIP SZ. 1) WAS IMPLANTED DUE TO A BOUCHARD'S NODE WITH PAIN. DURING A REGULAR FOLLOW-UP VISIT ON (B)(6) 2019, THE PATIENT COMPLAINED THAT THE FINGER HAD BECOME DIFFICULT TO EXTEND AND ON (B)(6) 2019 THE IMPLANT WAS REMOVED BY REVISION SURGERY DUE TO AN EARLY FRACTURE OF THE HINGE. THERE IS NO INFORMATION ABOUT OTHER TRAUMATIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670635 SILICONE PIP SZ. 1 SILICONE PIP KYJ ASCENSION ORTHOPEDICS 163711T

    Patients

    Seq Age Sex Outcome Treatment
    1