BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL STAND ALONE SYS

    MDR report key: 4203815 · Received July 23, 2014

    Report

    Report Number
    3008524126-2014-00018
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ORTHOFIX INC.
    Product Code
    OVE
    PMA / PMN Number
    K132999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, THE (B)(4) WAS DISCARDED BY THE HOSPITAL. ADDITIONAL INFO GATHERED ADVISED THAT THE BONE SCREW HAD STRIPPED. IN ADDITION, THE SURGEON WAS TRYING TO PULL THE INTERBODY DEVICE WHILE THE SCREW WAS STILL ANCHORED INTO THE BONE. WITH THE DETAILS PROVIDED IT CAN BE CONCLUDED THAT THE CAUSE OF THE COMPLAINT IS RELATED TO MISUSE OF THE DEVICE.

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED, THE SURGEON WAS REMOVING THE SCREW BECAUSE IT WAS TOO LONG. WHILE EXPLANTING THE SCREW, THE DRIVE FEATURE ON THE SCREW STRIPPED RESULTING IN A DELAY. THE SCREW WAS REPLACED AND THE PT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432588 CERVICAL STAND ALONE SYS DIA 3.6 PRIMARY BONE SCREW-14MM OVE ORTHOFIX INC. 83-3414 E04

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other