BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10054855 · Received May 14, 2020

    Report

    Report Number
    1030489-2020-00524
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Report Date
    May 14, 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

    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

    PRE DIAGNOSIS: BREAKAGE OF ROD PROCEDURE PERFORMED: REMOVAL OF BROKEN ROD WAS PERFORMED POST OP, REVISION SURGERY WAS PERFORMED BECAUSE THE LEFT AND RIGHT RODS BETWEEN L3 AND L5 BROKE AFTER PERFORMING FIXATION AT T11/IL (L4PVCR). ONLY THE LEFT SIDE OF L4 HAD SOME MOBILITY, AND BONE UNION WAS NOT COMPLETE. BONE GRAFT WAS PERFORMED AGAIN IN THIS OPERATION. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE. PATIENT SUFFERED LOWER BACK PAIN AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522141 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0567406W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R