BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9685113 · Received February 9, 2020

    Report

    Report Number
    1030489-2020-00158
    Event Type
    Malfunction
    Date Received
    February 9, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 9, 2020
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5541143, 510K # K132471 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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 PRESENTED WITH DEGENERATIVE SCOLIOSIS; AND UNDERWENT PLACEMENT OF SCREW AND HOOK AT T4-S2AI. POSTERIOR LUMBAR INTERBODY FUSION AT L2-L3 AND L5-S1 WAS ALSO BEING PERFORMED. INTRA-OP, WHILE MAKING AN ATTEMPT TO PLACE THE EXTENDED BODY HOOK ON THE TRANSVERSE PROCESS OF T4 FROM THE CRANIAL SIDE AND THE RAMPED LAMINA HOOK FROM THE CAUDAL SIDE TO THE TRANSVERSE PROCESS OR LAMINA OF T5, THE RAMPED LAMINA MIDDLE SIZED HOOK DID NOT FIT IN WELL. THIS MIDDLE SIZED RAMPED HOOK WAS TRIED AFTER THE ONE OF SMALL SIZE DID NOT FIT IN. ALTHOUGH CONFIRMATION HAD BEEN MADE USING A TRIAL BEFORE PLACING THE HOOK, THE HOOKS ON THE T4 CAUDAL SIDE COULD NOT BE PLACED. THEREFORE, ONLY THE EXTENDED BODY LARGE HOOK WAS SET. IT WAS A FIXATION OF LONG ROD, AND THE ROD ON THE CRANIAL SIDE APPEARED TO BE A LITTLE UNSTABLE AND THERE WAS A POSSIBILITY THAT A LARGE LOAD WAS APPLIED TO THE HOOK ON THE T4 CRANIAL SIDE. THE TWO HOOKS THAT COULD NOT BE PLACED ON THE CAUDAL SIDE OF THE T4 WERE ON THE RIGHT. IT WAS SAID THAT THERE WAS A POSSIBILITY THAT THE BASE OF THE TRANSVERSE PROCESS BROKE OFF AT THAT TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148372 CD HORIZON SPINAL SYSTEM NKB WARSAW ORTHOPEDICS NA 0531567W

    Patients

    Seq Age Sex Outcome Treatment
    1