BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2181784 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00953
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 7, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MACROSCOPIC AND OPTICAL INSPECTION IDENTIFY WITNESS MARKS AND ROUNDED CORNERS ON THE MAS BONE SCREW HEX, CONSISTENT WITH HEX STR IPPING. BONE SCREW FRACTURED AT THE BASE OF THE HEAD. VISUALLY CONFIRMED MAS BROKEN. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. UNABLE TO DETERMINE ROOT CAUSE OF INITIAL EVENT WITH THE AVAILABLE INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PEDIATRIC SCOLOSIS CASE, A SCREW INTERNAL HEX FAILED WHILE BEING USED ON A SELF RETAINING SCREW DRIVER. A SHORT ROD WAS USED WITH COUNTER TORQUE TO REMOVE AND SCREW SHAFT SNAPPED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK H07K6308

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR