BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6479317 · Received April 11, 2017

    Report

    Report Number
    1030489-2017-00785
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    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 PRODUCT WITH CATALOG# 54410004540 510K# K091974 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR FUSION FOR EXTENDING THE RANGE OF LUMBAR FIXATION. INTRA-OP SCREW WAS CROSS THREADED AS SET SCREW WAS PLACED OBLIQUELY AGAINST IT.THE SCREW AND THE SET SCREW WERE EX-PLANTED COMPLETELY. NO FRAGMENT OF THE BROKEN PRODUCTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263543 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