BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7017854 · Received November 10, 2017

    Report

    Report Number
    1030489-2017-02300
    Event Type
    Injury
    Date Received
    November 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THI PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 1475006040, 510K# K121680 AND (B)(4) IS APPROVED FOR SALE. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY REVIEW RESULTS: POST -OP X-RAY FROM L4-L5 TLIF SHOW ROD BACK OUT IN ONE OF THE SCREW HEADS L4-L5 CONSTRUCT IN THIS (B)(6) WITH A SIGNIFICANT DEFORMITY OF A THE UNSOLIDIFIED LUMBAR SACRAL ANATOMY WAS PERFORMED. GIVEN AGE ,POST BONE QUALITY AND EXTENSIVE DEFORMITY, CONSTRUCT FAILURE WAS LIKELY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE ROD ON THE LEFT SIDE OF L4 CAME OUT FROM THE SCREW HEAD. REVISION SURGERY WAS SCHEDULED FOR REPLACEMENT. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798296 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0243364W

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention