BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 3891025 · Received June 24, 2014

    Report

    Report Number
    1030489-2014-02859
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 AN UNKNOWN SPINAL PROCEDURE AND HAD ACHIEVED A SOLID FUSION. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT A SCREW WAS BROKEN. DURING THE REVISION PROCEDURE, WHILE TRYING TO REMOVE THE SCREW, IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367280 UNKNOWN SCREW HWC MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1