BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, BROACH, PROXIMAL, SZ. 30

    MDR report key: 3250338 · Received July 24, 2013

    Report

    Report Number
    1651501-2013-00021
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    NEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PIP (PROXIMAL INTERPHALANGEAL) BROACH BENT DURING SURGERY. ADDITIONAL INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345153 PIP, BROACH, PROXIMAL, SZ. 30 PIP INSTRUMENTS NEG ASCENSION ORTHOPEDICS 12-2060

    Patients

    Seq Age Sex Outcome Treatment
    1