BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTLELOC-P ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6668960 · Received June 26, 2017

    Report

    Report Number
    3008285983-2017-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    February 14, 2017
    Report Date
    March 9, 2017
    Manufacturer
    L&K BIOMED CO., LTD
    Product Code
    KWQ
    UDI-DI
    08806189893509
    PMA / PMN Number
    K143271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO AEGIS SPINE, THE PATHOLOGY DEPARTMENT OF THE HOSPITAL DID NOT PROVIDE THE DEVICES AND THEY ARE UNDER INVESTIGATION OF THE DEVICES. ADDITIONAL REQUEST WERE MADE TO THE AEGIS SPINE FOR DEVICE LOT NUMBER AND ITS RETURN BUT NO ADDITIONAL INFORMATION WAS OBTAINED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. L&K BIOMED WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, MED3 ASSOCIATES INC. (US DISTRIBUTOR OF AEGIS SPINE) REPORTED THE COMPLAINT TO AEGIS SPINE (US AGENCY OF L&K BIOMED), AND AEGIS SPINE REPORTED IT TO L&K BIOMED ON (B)(6) 2017. ACCORDING TO MED3 ASSOCIATES INC., DR. (B)(6) PERFORMED ACDF SURGERY ON (B)(6), 2016 USING CASTLELOC-P MODEL# IS 6712-1741 (2 LEVEL 41MM) AND LOT# IS UNKNOWN, AND UPON INVESTIGATION IT WAS DISCOVERED THAT THE CAM AT ONE OF THE C7 SCREWS HAD BROKEN OFF AT SOME POINT SINCE THE SURGERY IN (B)(6). THE PATIENT WAS ABOUT 7 WEEKS POST-OP AND DENIED FALLING OR ANY MOTOR VEHICLE ACCIDENT BUT HAS BEEN NON-COMPLIANT WITH HER NECK BRACE. DR.(B)(6) HAD RETRIEVED THE FREE-FLOATING CAM FROM THE PATIENT AND TOOK OUT THAT 16MM SCREW. HE DID NOT PUT IN A RESCUE SCREW BECAUSE THERE WAS NO LOCKING MECHANISM. MED3 ASSOCIATES INC. SAYS THAT THE PATIENT DOES NOT HAVE GREAT LORDOSIS AND IS RATHER STRAIGHT AND ALMOST KYPHOTIC ACCORDING TO PATIENT X-RAY PICTURE PROVIDED BY HOSPITAL, AND IT WAS SAID IT IS DIFFICULT TO ASSESS BUT I BELIEVE THERE MAY ALSO HAVE BEEN A NARROW DISK HEIGHT OF C7 - T1 ALONG WITH NOT WEARING HER NECK BRACE WHICH MAY HAVE CONTRIBUTED TO THE FORCES THAT WERE GENERATED TO CAUSE THE SCREW TO BACK OUT AND SUBSEQUENTLY PUSH THE CAMLOCK OFF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447571 CASTLELOC-P ANTERIOR CERVICAL PLATE SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ L&K BIOMED CO., LTD 6712-1741 UNDER INVESTIGATION 08806189893509

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S