BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2271516 · Received October 3, 2011

    Report

    Report Number
    1030489-2011-01239
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE LOTS THAT WERE USED ARE PART# G7540020, LOT H10K3012, EXPIRATION DATE 11/17/2018; LOT H11D1102, EXPIRATION DATE 04/13/2019; PART #G75446545, LOT H10L1271, EXPIRATION 12/29/2018; LOT H10L1276, EXPIRATION DATE 12/03/2018; PART G8115539, LOT 0089597W, EXPIRATION DATE 04/15/2018. G5: THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7540020 510K # K052187 WAS CLEARED IN THE UNITED STATES, 75446545 510K # K042025 WAS CLEARED IN THE UNITED STATES, 8115539 510K # K030840 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10K3012 IS 10/27/2010; THE MANUFACTURE DATE FOR LOT H11D1102 IS 04/06/2011; THE MANUFACTURE DATE FOR LOT H10L1271 IS 11/08/2010; THE MANUFACTURE DATE FOR LOT H10L1276 IS 11/13/2010; THE MANUFACTURE DATE FOR LOT 0089597W IS 04/26/2010. 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 POSTERIOR LUMBAR SURGICAL PROCEDURE AT L4-L5. IT WAS REPORTED THAT LESS THAN TWO MONTHS POST-OP THE PATIENT UNDERWENT REVISION SURGERY BECAUSE THE PATIENT SHOWED NO IMPROVEMENT SINCE THE SECOND SURGERY; THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL AND UNDERWENT THIRD SURGERY TO REMOVE THE DEVICES EXCEPT THE CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention RODS, SCREWS, VB REPLACEMENTS