BEUDAMED
    FDA Adverse Event Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2041241 · Received April 6, 2011

    Report

    Report Number
    1030489-2011-00384
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED DRIVER TIP BROKEN. MICROSCOPIC EXAMINATION REVEALS A QUASI-BRITTLE FRACTURE SURFACE WITH SIGNIFICANT DAMAGE NOTED, WITH NO EVIDENCE OF FATIGUE; SOME EVIDENCE OF TORSION APPLIED TO FRACTURE AFTER INITIAL CRACK PROPAGATION, SUGGESTING BEND STRESS OVERLOADING AS THE MECHANISM OF CRACK PROPAGATION, WITH SECONDARY TORSION. APPROX. ~½ THREAD OF MAS HEAD ENGAGEMENT THREAD DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN THE MULTI AXIAL SCREW. THE TIP COULD NOT BE REMOVED FROM THE SCREW. THE ROD WAS ABLE TO BE PROPERLY SEATED AND THE SET SCREW PROPERLY SEATED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT HXX MEDTRONIC SOFAMOR DANEK NA MG09335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCREW