BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1628937 · Received March 9, 2010

    Report

    Report Number
    1530901-2010-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 9, 2010
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    NEW
    PMA / PMN Number
    K080680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SPOKE WITH THE DISTRIBUTOR REP ON (B)(4) 2010 ABOUT THE INCIDENT. DURING FINAL TIGHTENING OF THE FINAL SCREW, THE SPRING ARM LOCKED & THE SURGEON THEN ATTEMPTED TO TIGHTEN AN ADDITIONAL 1/4 TURN TO GET A TIGHTER FIT. AT THAT POINT, THE INSTRUMENT TIP BROKE OFF. THE SURGEON THEN TOOK A MINUTE TO TRY TO PICK & SUCTION THE TIP OUT OF THE SCREW BEFORE MOVING ON AND COMPLETING THE SURGERY. THERE WERE NO OTHER ISSUES WITH THE SURGERY. THE DRIVER HAS BEEN RETURNED FOR EVALUATION, AND THE INSTRUMENT FAILURE WAS VERIFIED. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS BATCH OF INSTRUMENT DOES NOT SHOW ANY NONCONFORMANCES OR ISSUES THAT WOULD CONTRIBUTE TO THIS ISSUE.

    Description of Event or Problem · 1

    DURING FINAL TIGHTENING, THE SCREW INSERTER TIP BROKE OFF AND BECAME STUCK IN THE HEAD OF THE SCREW. THE SURGEON WAS UNABLE TO REMOVE THE INSTRUMENT TIP, AND LEFT IT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM ANTERIOR SPINAL FIXATION SYSTEM NEW THEKEN SPINE LLC 22-40-0305 W10597

    Patients

    Seq Age Sex Outcome Treatment
    1