BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETSCREW OBTURATOR

    MDR report key: 3243075 · Received July 23, 2013

    Report

    Report Number
    1030489-2013-03083
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 19, 2013
    Report Date
    September 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS OF THE INSTRUMENT IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT. INSPECTION OF THE SHAFT DIAMETER CONFIRMED CONFORMANCE TO PRINT SPECIFICATION.

    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 REVISION PROCEDURE, FOR A SCREW REVISION FROM A SCOLIOSIS CASE. DURING THE PROCEDURE, THE OBTURATOR BROKE WHILE UNSCREWING THE SET SCREW. THE TIP OF THE INSTRUMENT BROKE AND FELL INTO THE WOUND. THE TIP WAS ABLE TO BE REMOVED WITH NO COMPLICATIONS. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343895 SETSCREW OBTURATOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC JM07G003

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR