BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8415812 · Received March 13, 2019

    Report

    Report Number
    1030489-2019-00278
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    October 3, 2018
    Report Date
    March 13, 2019
    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 SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 54840007535 ,510K# K091974 AND UDI (B)(4) IS APPROVED FOR SALE IN US. PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC VISUAL AND MICROSCOPIC INSPECTION CONFIRMED THE TOP SURFACE OF THE MAS HAS BEEN DAMAGED FROM WHAT APPEARS TO BE AN IMPACT. THE DAMAGE HAS DEFORMED THE FIRST THREAD OF THE SCREW HEAD NOT ALLOWING THE DRIVER TO BE ATTACHED. THIS IS CONSISTENT WITH MATERIAL OVERLOAD CAUSING THREAD DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FROM L3-L5 DUE TO LUMBAR CANAL STENOSIS. IN TRA-OP, WHILE PERFORMING FINAL TIGHTENING AT LEFT L5 THREADS OF THE IMPLANTING SCREW WERE DAMAGED. HENCE, SCREW WAS REMOVED FROM THE PATIENT BODY. PATIENT COMPLICATIONS REPORTED AS UNKNOWN DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210098 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5377132

    Patients

    Seq Age Sex Outcome Treatment
    1