BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1932260 · Received December 17, 2010

    Report

    Report Number
    1030489-2010-01604
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT# OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT #H10G3856, EXPIRATION DATE IS 09/01/2018; H10G3867, EXPIRATION DATE 08/31/2018; H10H1371, EXPIRATION DATE 08/30/2018; AND H10H2371, EXPIRATION DATE 09/01/2018. 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 H10G3856 IS 09/01/2010; THE MANUFACTURE DATE FOR LOT H10G3867 IS 08/31/2010; THE MANUFACTURE DATE FOR LOT H10H1371 IS 08/30/2010; THE MANUFACTURE DATE FOR LOT H10H2371 IS 09/01/2010. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 PLIF AT L5-S1 USING POSTERIOR FIXATION. DURING THE FINAL TIGHTENING, THE COUNTER DRIVER COULD NOT BE PLACED ON THE SET SCREW DUE TO THE SET SCREW CROSS THREADING. A NEW SET SCREW WAS REPLACED AND THE COUNTER DERIVER THEN COULD BE PLACED. THE CASE WAS COMPLETED WITHOUT ADDITIONAL COMPLICATIONS. NO PATIENT INJURY WAS 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 PUERTO RICO OPERATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 DA