BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1854162 · Received September 3, 2010

    Report

    Report Number
    1030489-2010-01125
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER.
    Product Code
    NKB
    PMA / PMN Number
    K052187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT# H10C5026, #H10E0651, AND #H10E0916. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10C5026 IS (B)(4) 2010; THE MANUFACTURE DATE FOR LOT H10E0651 IS (B)(4) 2010; THE MANUFACTURE DATE FOR LOT H10E0916 IS (B)(4) 2010. NEITHER THE DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT T5-T7. THE SET SCREW WAS CROSS THREADED WHEN LOADED ONTO THE PEDICLE SCREW HEAD. IT WAS REPLACED. NO PT COMPLICATION IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDICLE SCREWS| IMPLANT: