BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5649717 · Received May 12, 2016

    Report

    Report Number
    1030489-2016-01378
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 14, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE-H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:VISUAL AND OPTICAL EXAMINATION OF THE HEX IDENTIFIED MATERIAL PARTICLES CONSISTENT WITH SIGNIFICANT OVER-TORQUE OF THE SET SCREW, RESULTING IN STRIPPING. 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.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8115545, 510K # K030840 WAS CLEARED IN THE UNITED STATES. (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT.

    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: HERNIATION BETWEEN L3 AND L4 DUE TO ADJACENT SEGMENTAL DISORDER AFTER "PLF" SURGERY AT L4/5 PROCEDURE: REVISION SURGERY WAS PERFORMED FOR EXTENTION LEVELS AT L3 AFTER "PLF" SURGERY AT L4-5 IT WAS REPORTED THAT, INTRA-OP, THE SURGEON TRIED TO REPLACE A CROSSLINK BECAUSE AFTER PLACING A ROD, HE IMPLANTED THE CROSSLINK BETWEEN L4 AND L5 BUT THE IMPLANTED CROSSLINK APPEARED TO BE TOO HIGH TO CLOSE THE INCISION. SO THE SURGEON DECIDED TO REMOVE IT BUT ITS THREAD WAS STRIPPED DURING REMOVING, IT COULD NOT BE REMOVED AT ALL. FINALLY, THE PLACED ENTIRE ROD WAS REMOVED RELUCTANTLY. REASON FOR REVISION: AFTER "PLF" SURGERY AT L4/5, HERNIATION WAS OBSERVED DUE TO ADJACENT SEGMENTAL DISORDER SO REVISION SURGERY ("PLF") WAS PERFORMED TO EXTENSION LEVELS. THE PRODUCTS CAME IN THE CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO FRAGMENTS REMAINED IN THE PATIENT. WHEN REMOVAL, THE SET SCREW HEAD OF THE CROSSLINK ROUNDED OFF AND COULD NOT BE REMOVED. ANOTHER SET SCREW OF THE CROSSLINK WAS ABLE TO BE REMOVED WITH THE SAME DRIVER WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305405 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0411108W

    Patients

    Seq Age Sex Outcome Treatment
    1