BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6470878 · Received April 7, 2017

    Report

    Report Number
    1030489-2017-00764
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    March 13, 2017
    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

    THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 1556200500 , 510K# K131321 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH KYPHOSIS UNDERWENT POSTERIOR SPINAL FUSION AT LEVELS L3-S1. ON AN UNKNOWN DATE, POST-OP, ROD AT LEFT SIDE WAS BROKEN BETWEEN L5-S1. BONE UNION WAS NOT GOOD AT L5-S1. LOWER LIMBS PAIN HAS BEEN OBSERVED BUT IT IS UNKNOWN WHETHER THE ROD BREAKAGE WAS RELATED WITH THE PAIN SO THE PATIENT IS FOLLOWED UP THERE IS NO PLAN OF REMOVING THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255247 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other