BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7385674 · Received March 30, 2018

    Report

    Report Number
    1030489-2018-00501
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 1, 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

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC INSPECTION REVEALED THE THREADS OF THE BREAK OFF SCREW HAVE BEEN DAMAGED. THE THREADS HAVE BEEN ROLLED OVER FROM WHAT APPEARS TO BE SOME SORT OF PLIERS THAT WERE USED TO BACK THE SCREW OUT SINCE THE TIP OF THE DRIVER WAS BROKEN OFF IN THE SET SCREW. THE ROOT CAUSE OF FAILURE IS UNDETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R REPORTED EVENT. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440230, 510K #K112473 , UPN# (B)(4) WAS CLEARED IN THE UNITED STATES. 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 FOR THIS PROCEDURE : AIS TYPE OF PROCEDURE OR TECHNIQUE USED : CORRECTION FIXATION IT WAS REPORTED THAT INTRA-OP, SET SCREW WAS INSERTED AND IT WAS TRIED TO BE BROKEN OFF WITH THE T25 SHAFT, BUT THE TIP OF THE T25 WAS BROKEN. THE SET SCREW COULD NOT BE BROKEN OFF. NO FRAGMENT REMAINING IN THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. THE FRAGMENT WAS WASHED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228085 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5368580

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR