BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8467914 · Received March 30, 2019

    Report

    Report Number
    1030489-2019-00355
    Event Type
    Malfunction
    Date Received
    March 30, 2019
    Date of Event
    March 6, 2019
    Report Date
    September 11, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    PRODUCT ANALYSIS: AFTER VISUAL AND OPTICAL EXAMINATION, IT APPEARS THAT THREADS OF THE SET SCREW ARE CROSS-THREADED/DAMAGED. THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREAD. THE RESULTS ARE CONSISTENT WITH MISALIGNMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 6430530 AND 510K# K143375 AND UDI# (B)(4), IS APPROVED FOR SALE IN THE US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR FUSION AT L3. INTRA-OP, WHEN ATTEMPTING TO PERFORM FINAL TIGHTENING OF THE SET SCREW AT L3, THE PRODUCT IDLED. THE PROBLEM WAS SOLVED WHEN THE SCREW WAS REPLACED. AFTER THE OPERATION, WHEN THE SCREW WAS CHECKED, IT WAS FOUND THAT THE SCREW TAB WAS BENT. THREAD OF THE SET SCREW WAS FOUND TO BE SHAVED. LOCKING CAP WAS NOT ATTACHED TO THE TAB EXTENDER WHEN INSERTING THE SET SCREW, AND THERE WAS A GAP BETWEEN THE ROD AND THE SCREW HEAD. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260638 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0648962W

    Patients

    Seq Age Sex Outcome Treatment
    1