BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9788124 · Received March 4, 2020

    Report

    Report Number
    1030489-2020-00256
    Event Type
    Injury
    Date Received
    March 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    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

    PMA/510K: THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 1606200500, 510K# K131321 AND UDI# (B)(4) IS APPROVED FOR SALE IN 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 PRESENTED WITH ADULT DEFORMITY; AND UNDERWENT POSTERIOR SPINE CORRECTION AND DECOMPRESSION FIXATION AT T9-S2. ON AN UNKNOWN DATE, POST-OP, THE RODS ON BOTH SIDES BROKE-OFF BETWEEN L5 AND S2. ALLEGEDLY, RODS BREAKAGE WERE CAUSED DUE TO BONE UNION FAILURE. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN RODS WERE REPLACED. NO FRAGMENT OF THE BROKEN RODS REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252094 CD HORIZON SPINAL SYSTEM NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention