BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5570840 · Received April 12, 2016

    Report

    Report Number
    1030489-2016-01090
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    March 16, 2016
    Report Date
    April 18, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR EVICE WITH CATALOG NUMBER 9795315 AND 510K# K042922 IS APPROVED IN US. (B)(4). THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL AND OPTICAL EXAMINATION OF THE BONE SCREW IDENTIFIED THREAD CREST DAMAGE,CONSISTENT WITH CONTACT WITH PLATE DURING INSERTION.

    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 UNDERWENT A ANTERIOR FUSION SURGERY FOR THE C5 FRACTURE AND EXTENSION TO T1 (WITH C5 SKIPPED). INTRAOPERATIVELY,WHEN THE SURGEON INSERTED THE SPINAL SCREW THROUGH THE SPINAL PLATE, THE SCREW STRIPPED AND BURRS WERE FOUND AT THE SHAFT OF SCREW. BURRS WERE REMOVED. THE SCREW WAS REPLACED WITH NEW ONE AND THE PLATE IMPLANTATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227386 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H09F7718

    Patients

    Seq Age Sex Outcome Treatment
    1