BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01348

    MDR report key: 2993846 · Received March 8, 2013

    Report

    Report Number
    2520274-2013-01348
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 MATRIX MANDIBLE PLATE AND MATRIX MANDIBLE LOCKING SCREWS IN (B)(6) 2011 (DATE UNKNOWN). IT WAS REPORTED THE PATIENT HAD COMPROMISED HEALTH AND WAS PRESENTED WITH AN INFECTION. IT WAS ALSO REPORTED, THE PLATE HAD MIGRATED THROUGH THE SKIN. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. NO ADDITIONAL HARDWARE WAS IMPLANTED AS THE BONE WAS FULLY HEALED. PATIENT WAS TREATED WITH ANTIBIOTICS. THIS REPORT IS FOR THE UNKNOWN MATRIX MANDIBLE LOCKING SCREW. THIS IS 3 OF 7 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100056 JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention