BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7327778 · Received March 9, 2018

    Report

    Report Number
    1030489-2018-00362
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 9, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840005540, 510K # K091974, UPN: (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LEVELS IMPLANTED: L2/3 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPINAL CANAL STENOSIS AND UNDERWENT POSTERIOR LUMBAR FUSION AT L2-L3, INTRA-OP, L2 LEFT PEDICLE SCREW DEVIATED TO LATERAL. THE SCREW DID NOT BREAK. THE IMPLANT REMAINED IN THE STATUS OF DEFECTIVE INSTALLATION. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169538 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5259213

    Patients

    Seq Age Sex Outcome Treatment
    1