BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4706577 · Received April 20, 2015

    Report

    Report Number
    2520274-2015-13163
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    April 7, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR AN UNKNOWN TITANIUM SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. 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. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE. CLAYMAN, L. & ROSSI, E. (2012) "FIXATION OF ATROPHIC EDENTULOUS MANDIBLE FRACTURES BY BONE PLATING AT THE INFERIOR BORDER." JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 70, 883-889. A CONSECUTIVE CASE SERIES DURING A 30-YEAR PERIOD AT A UNIVERSITY MEDICAL CENTER REVIEWING THE USE OF SYNTHES PLATES AND COMPETITOR PLATES TO REPAIR FRACTURES OF SEVERELY ATROPHIC MANDIBLES. THERE WERE SIXTEEN PATIENTS, 10 MALE AND 6 FEMALE RANGING IN AGE FROM 30 TO 84 YEARS THAT WERE REVIEWED DURING THE 30-YEAR PERIOD. AN UNKNOWN PATIENT EXPERIENCED SCREW LOOSENING. THIS REPORT IS 3 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TITANIUM SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260115 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1