BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7928571 · Received October 2, 2018

    Report

    Report Number
    1030489-2018-01320
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    February 13, 2018
    Report Date
    October 2, 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT ANALYSIS: THERE IS VISUAL DEFORMATION TO THE INTERAL TORX THREAD OF THE SET SCREWS. THIS DAMAGED APPEARS TO HAVE OCCURED DURING THE REMOVAL PROCESS OF THE SET SCREWS. THERE APPEARS TO BE ENOUGH MATERIAL LEFT ON THE TORX FOR THE SCREWS TO STILL ENGAGE THE DRIVER. 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 : CONGENITAL SCOLIOSIS IT WAS REPORTED THAT INTRA-OP, WHEN THE DOCTOR ATTEMPTED TO REMOVE THE SET SCREW STRIPPING OCCURRED AND IT COULD NOT BE REMOVED. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768290 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5350333

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR