BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3035162 · Received April 4, 2013

    Report

    Report Number
    1030489-2013-00932
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 7, 2012
    Report Date
    March 6, 2013
    Manufacturer
    H10
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR: (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 PART# G8698501, LOT 0161760W; PART # G8698500, LOT 0133356W; PART G7540020, LOT H11B6729, H11D1116, H12A4030; PART G7543640, LOT H10J0895; PART G7543645, LOT H10H3701, LOT H10K0617; PART G7543650, LOT H10E0323; PART G8110614, LOT 0197508W. (B)(6). (B)(4). PMA/510K: THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER LIKE DEVICES CATALOG # 8698501, 8698500, 8110614, 510K # K010249; CATALOG # 7540020, 510K # K052187; CATALOG #7543640, 7543645, 7543650, 510K # K031655; WERE CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0161760W IS 06/20/2011; THE MANUFACTURE DATE FOR LOT 0133356W IS 01/14/2011; THE MANUFACTURE DATE FOR LOT H11B6729 IS 12/23/2011; THE MANUFACTURE DATE FOR LOT H11D1116 IS 05/03/2011; THE MANUFACTURE DATE FOR LOT H12A4030 IS 02/13/2012; THE MANUFACTURE DATE FOR LOT H10J0895 IS 10/14/2010; THE MANUFACTURE DATE FOR LOT H10H3701 IS 09/13/2010; THE MANUFACTURE DATE FOR LOT H10K0617 IS 11/26/2010; THE MANUFACTURE DATE FOR LOT H10E0323 IS 06/29/2010; THE MANUFACTURE DATE FOR LOT 0197508W IS 01/31/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A VERTEBROPLASTY TO TREAT A COMPRESSION FRACTURE USING A COMPETITOR S PRODUCT. THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PSEUDOARTHROSIS AND KYPHOSIS AT L2-L4 WITH A CORPECTOMY AT L3. 7 MONTHS POST-OP THE PATIENT UNDERWENT ANOTHER SURGERY DUE TO INFECTION. PER THE REPORT, CRP DID NOT DECREASE AND PURULENT DISCHARGE HAD BEEN OBSERVED POST-OP. SINCE THE SYMPTOMS DID NOT IMPROVE, ALL IMPLANTS WERE REMOVED AND THE IRRIGATION WAS PERFORMED. BONE FUSION HAS BEEN COMPLETED. A POSTERIOR FIXATION WILL BE ADDED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139148 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP H10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention SCREWS, STAPLES, CROSSLINK