BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOX ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5229380 · Received November 13, 2015

    Report

    Report Number
    3004717358-2015-00001
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 12, 2015
    Manufacturer
    SPINECRAFT
    Product Code
    KWQ
    UDI-DI
    M824VPH22361
    PMA / PMN Number
    K131521
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED EVENT PROBLEM AND EVALUATION CODES TO BETTER MATCH THE CODES AVAILABLE IN ESUBMITTER AND DESCRIBE THE EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL, MFG, STORAGE AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS OF THE PRODUCT USED. THE RECORDS REVEALED THAT ALL PRODUCT LOTS FOR THIS ITEM SHIPPED WERE MANUFACTURED WITHIN SPEC, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL APPROVED COMPANY PROCEDURES. THE RETAINED DHR SAMPLE WAS INSPECTED FOR LOOSE OR DEFORMED RINGS. THE PLATE EXHIBITED NO REMARKABLE VARIATIONS OR ISSUES. IN-HOUSE EVAL WAS PERFORMED IN AN ATTEMPT TO REPLICATE CONDITIONS NECESSARY TO CREATE A SCENARIO WHERE THIS EVENT IS POSSIBLE. THE ONLY CONDITION THAT WE WERE ALBE TO CREATE A SITUATION WHERE THE RING BECAME DISLODGED IS WHEN WE PURPOSEFULLY INTRODUCED A POINTED INSTRUMENT (TWEEZER-TYPE FORCEPS, NOT DESIGNED TO BE USED WITH THE SYSTEM, BETWEEN THE RING AND THE PLATE.) THEREFORE, WE CONCLUDE THAT THE ISSUE OBSERVED IN THIS INSTANCE WAS CAUSED BY IMPROPER HANDLING OF THE PLATE WITH AN INSTRUMENT NOT SPECIFICALLY DESIGNED TO INTERFACE WITH THE PLATE.

    Description of Event or Problem · 1

    SURGEON WAS USING THE VELOX PLACE DURING A 2-LEVEL ACDF SURGERY. DURING SCREW PLACEMENT, THE SURGEON NOTICED THAT ONE OF THE MIDDLE RINGE WAS SLIGHTLY MISALIGNED AND TURNED CLOCK-WISE. THE SURGEON CONTINUED TO DRIVE THE SCREW UNTIL IT WAS SECURE. THE RING DID NOT MOVE, BUT APPEARED TO BE BELOW THE PLATE IN AN X-RAY THAT WAS OBSERVED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753453 VELOX ANTERIOR CERVICAL PLATE SYSTEM PLATE KWQ SPINECRAFT 67299 M824VPH22361

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR