BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 3582508 · Received January 17, 2014

    Report

    Report Number
    1030489-2014-00172
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE USING ANTERIOR APPROACH AT L5-S1. "ONE OF THE STABILITY PINS BROKE INTO THE VERTEBRAE OF THE PATIENT, THE BROKEN PIECE OF THE INSTRUMENT COULD NOT BE REMOVED." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45319 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1