BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANDIBLE-CORTSCR Ø2 SELF-TAP L8 TI

    MDR report key: 3082267 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02226
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. DATE OF EVENT WAS REPORTED AS 2003. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN THE YEAR 2000, PATIENT HAD FIRST VISIT WITH ORTHOTIC PRACTICE TO PREPARE FOR JAW DEFORMITY SURGERY. PATIENT WAS IMPLANTED WITH HARDWARE FOR JAW DEFORMITY ON (B)(6) 2002 DUE TO MANDIBULAR PROGNATHISM. IT IS REPORTED THAT AT THIS TIME, SURGEON PERFORMED SAGITTAL SPLITTING METHOD OF MANDIBULAR RAMUS AND PERFORMED A SETBACK PROCEDURE. POST-OPERATIVELY, IN 2003, PATIENT HAD A NEUROPLEGIA AROUND THE MANDIBLE AND HYPAESTHESIA AROUND THE LOWER JAW ON BOTH SIDES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 9 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185659 MANDIBLE-CORTSCR Ø2 SELF-TAP L8 TI HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1