BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM

    MDR report key: 4211183 · Received October 29, 2014

    Report

    Report Number
    2520274-2014-14417
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    PK072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION (ACDF) SURGERY ON (B)(6), 2014 AT LEVEL C4-5. AFTER THE SURGEON FINAL TIGHTENED THE 3.0MM TITANIUM CERVICAL SPINE LOCKING SCREW IT WAS NOTICED THAT A THREAD OF THE SCREW WAS HANGING OFF. A BAYONET WAS USED TO REMOVE IT. THE ZERO-P IMPLANT 7MM HEIGHT LORDOTIC AND SCREW WERE UNDAMAGED AND REMAIN IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM. NO DELAY WAS NOTED. THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692320 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM INTERVERTEBRA; FUSOIN DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR