BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ 40 PROXIMAL

    MDR report key: 3763398 · Received April 7, 2014

    Report

    Report Number
    1651501-2014-00020
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    December 12, 2013
    Report Date
    March 14, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWF
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THIRD PROXIMAL PIP IMPLANT OF THE LEFT HARD OF THE PT "SNAPPED AFTER HIS HAND GOT 'WRANGLED, IN THE LEASH OF HIS (B)(6) GOLDEN RETRIEVER. ON (B)(6), 2014, THE PT CONSULTED WITH HIS SURGEON. AN X-RAY WAS PERFORMED WHICH REVEALED THAT THE PROXIMAL TIP OF THE PIP WAS BROKEN. THE PT WAS SCHEDULED FOR REVISION SURGERY ON (B)(6), 2014. ADD'L INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207680 PIP SZ 40 PROXIMAL PIP KWF ASCENSION ORTHOPEDICS 05-0677

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention