BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3639861 · Received February 21, 2014

    Report

    Report Number
    2520274-2014-00648
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K050608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL CODE: DZL. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC SURGEON WAS REPAIRING A ZYGOMATIC COMPLEX (ZMC) FRACTURE ON (B)(6) 2014 WHEN THE HEAD OF A 5.0MM MATRIX MIDFACE SCREW FAILED DURING INSERTION INTO THE FRACTURE SUTURE. THE HEAD OF THE SCREW SHEARED OFF BEFORE THE SURGEON WAS ABLE TO TIGHTEN IT COMPLETELY. THE SCREW HEAD SHEARED OFF EVEN WITH THE BONE SO REMOVAL WAS NOT NECESSARY. THE SURGEON WAS ABLE TO SECURE THE 0.7MM ORBITAL RIM PLATE USING ADDITIONAL SCREWS, WHICH HE THEN PRE-DRILLED. THE HEAD OF THE SCREW WAS SUBSEQUENTLY LOST. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110072 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR