BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7471720 · Received April 30, 2018

    Report

    Report Number
    1030489-2018-00615
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 2, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MULTI-PACK DEVICE CONSISTS OF SET SCREWS WITH PART# 5430130 WHICH IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 5440130, 510K#K102555 AN UPN (B)(4) IS MARKETED IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC FUNCTIONAL NO FAULT FOUND. FUNCTIONS AS INTENDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE: POSTERIOR LUMBAR FUSION IT WAS REPORTED THAT THE IMPLANTED SET SCREW BACKED OUT AFTER OPERATION. THE BACKED OUT SET SCREW WAS REPLACED. THERE WAS NO PATIENT COMPLICATION AS OF NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316563 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5367176

    Patients

    Seq Age Sex Outcome Treatment
    1