BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2945087 · Received February 6, 2013

    Report

    Report Number
    1030489-2013-00382
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUALLY CONFIRMED THE TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT DUCTILE FRACTURE WITH CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. MATERIAL HARDNESS CONFIRMS CONFORMANCE TO PRINT SPECIFICATIONS. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    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 THE TIP OF THE DRIVER BROKE OFF DURING USE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51079 CD HORIZON SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG NA DC08M023

    Patients

    Seq Age Sex Outcome Treatment
    1