BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

    MDR report key: 3655386 · Received March 3, 2014

    Report

    Report Number
    2520274-2014-10048
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THIS REPORT IS FOR 1 UNKNOWN PLATE/UNKNOWN LOT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBILITY DURING A TWO LEVEL CERVICAL CASE THAT THE CERVICAL SPINE LOCKING PLATES SCREW MAY HAVE PASSED THROUGH THE SCREW HOLE OF THE CERVICAL SPINE LOCKING PLATES VARIABLE ANGLE PLATE. THE SURGEON COMPLETED THE SURGERY WITHOUT CHANGING OUT EITHER ITEM. THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL MEDICAL INTERVENTION. THE PATIENT STATUS/OUTCOME IS CURRENTLY UNKNOWN. THIS REPORT IS FOR AN UNKNOWN CERVICAL SPINE LOCKING PLATES VARIABLE ANGLE PLATE.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBILITY DURING A TWO LEVEL CERVICAL CASE THAT THE SCREW MAY HAVE PASSED THROUGH THE SCREW HOLE OF THE PLATE. THE PLATE WAS A VARIABLE ANGLE TWO LEVEL PLATE. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127109 APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1