BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6515085 · Received April 24, 2017

    Report

    Report Number
    1030489-2017-00973
    Event Type
    Injury
    Date Received
    April 24, 2017
    Report Date
    March 30, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 54840007535 ,510K# K091974 AND (B)(4) IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WERE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH L4 SPONDYLOLISTHESIS UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4/5. POST-OPERATIVELY, ALL 4 SCREWS WERE LOOSENED AND NEUROLOGIC SYMPTOM OCCURRED IN THE PATIENT. PATIENT DIDN'T ACHIEVE SOLID FUSION. AS A RESULT, REVISION SURGERY IS SCHEDULED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297608 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R