BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3061051 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-01986
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CERVICAL SPINE LOCKING SCREW ON (B)(6) 2011. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ZERO P SCREW BACKED OUT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163665 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR