BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL PLUG DRIVER-LONG

    MDR report key: 4113692 · Received September 17, 2014

    Report

    Report Number
    2184052-2014-00178
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC CAUSE OF THE BROKEN INSERTER COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE IS RELATED TO SURGICAL CONTEXT.

    Description of Event or Problem · 1

    DURING SURGERY AN INSERTER BENT AND THE TIP BROKE OFF INSIDE A SET SCREW. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE AND THE SET SCREW COULD NOT BE FINAL TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575603 PROVISIONAL PLUG DRIVER-LONG PROVISIONAL PLUG DRIVER-LONG MAX ZIMMER SPINE, INC. 777-03 56FP

    Patients

    Seq Age Sex Outcome Treatment
    1