BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 7192751 · Received January 16, 2018

    Report

    Report Number
    1030489-2018-00065
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 16, 2018
    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

    ALTHOUGH IT IS UNKNOWN IF THE CONCERNED DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. ABOVE MENTIONED DEVICE WITH QUANTITY OF 2 WAS INVOLVED IN THE EVENT. THE CONCERNED PRODUCT IS A MULTI-PACK WHICH CONTAINS FOUR DEVICES WITH PART# 6430530. THIS PRODUCT IS NOT AVAILABLE FOR MARKET IN THE US. HOWEVER, A LIKE DEVICE WITH PART# 6430530, 510K# K143375 AND UDI# 00643169545281 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

    PRE-OP DIAGNOSIS: KYPHOSCOLIOSIS PROCEDURE: POSTERIOR PEDICLE SCREW(PPS) FIXATION LEVELS IMPLANTED: L2-5 IT WAS REPORTED THAT DURING SURGERY, AFTER FINAL TIGHTENING, METAL PIECES WERE CONFIRMED AND REMOVED FROM THE WOUND ON THE RIGHT SIDE OF L3. THERE WAS A GAP BETWEEN THE ROD AND THE SCREW SOMEWHAT, IT SEEMED THE SET SCREW PUSHED THE ROD DOWN ONTO THE SCREW. IT WAS UNKNOWN WHETHER THE IMPLANTED PRODUCTS BROKE OR NOT. NO METAL PIECES WERE REMAINING IN THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42008 CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0603440W

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS, RODS