BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY- SPINE

    MDR report key: 580516 · Received February 24, 2005

    Report

    Report Number
    580516
    Event Type
    Malfunction
    Date Received
    February 24, 2005
    Date of Event
    January 25, 2005
    Report Date
    February 18, 2005
    Manufacturer
    DEPUY SPINE
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED SCREW REMOVER INTO SPINAL SCREW. TRIED TO REMOVE SCREW (SEVERAL ATTEMPTS). SCREW DID NOT MOVE AND TIP OF REMOVER BROKE OFF AND REMAINED IN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY- SPINE SCREW REMOVER EKS DEPUY SPINE * AG0398C

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR