BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 7499180 · Received May 9, 2018

    Report

    Report Number
    1030489-2018-00654
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS A PACK OF FOUR PRODUCTS WITH PART# 6430530, 510K# K143375 AND UDI# (B)(4), WHICH IS AVAILABLE FOR MARKET IN THE US. H6: 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-OPERATIVE DIAGNOSIS: BURST FRACTURE. TYPE OF PROCEDURE: FUSION FOR BURST FRACTURE. LEVELS IMPLANTED: L2-S IT WAS REPORTED THAT POST-OPERATIVELY, THE SET SCREW BACKED OUT FROM THE SCREW HEAD COMPLETELY. THE DEVICE COME IN CONTACT WITH THE PATIENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.¿ UPDATE RECEIVED ON (B)(6) 2018: THE PATIENT WAS PERFORMED L2-S (2A2B) FUSION DUE TO L4 BURST FRACTURE. AFTER OPERATION, SET SCREWS OF S BACKED OUT ON BOTH SIDES(THE QUANTITY OF THE REPORTED PRODUCT WAS WRONG. THERE ARE 2 SET SCREWS.). THE SET SCREW BACKED OUT FROM THE SCREW HEAD COMPLETELY. THE PHYSICIAN SUSPECTED THAT THE EVENT OCCURRED DUE TO HIS OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341790 CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0581656W

    Patients

    Seq Age Sex Outcome Treatment
    1