BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 6452527 · Received April 3, 2017

    Report

    Report Number
    1030489-2017-00728
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 8, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH LUMBAR DISCOPATHY UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, THE SURGEON USED THE ENDORING SYSTEM. AFTER THE SURGEON IMPACTED THE ANTERIOR CAGE, HE HAD TO REMOVE THE ENDORING IN ORDER TO FINISH THE SURGERY BUT WHEN THE SURGEON HAD REMOVED THE ENDORING PINS, ONE OF THEM BROKE AND THE EXTREMITY DISTAL OF THE PIN STAYED IN THE VERTEBRAL BODY OF THE PATIENT. DISTAL EXTREMITY OF THE ENDORING PIN REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY IT WAS REPORTED THAT THERE WILL NOT BE ANY REVISION SURGERY AS PATIENT'S HEALTH IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236566 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK NA 897-405

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other