BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7393053 · Received April 3, 2018

    Report

    Report Number
    8030965-2018-52720
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    February 27, 2013
    Report Date
    March 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S INFORMATION IS UNKNOWN. 510K: THIS REPORT IS FOR AN UNKNOWN UNILOCK PLATE 2.4, ANGLED./UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE LITERATURE ARTICLE: MENSINK, G., ET AL., (2013) BILATERAL SAGITTAL SPLIT OSTEOTOMY IN A MANDIBLE PREVIOUSLY RECONSTRUCTED WITH A NONVASCULARIZED BONE GRAFT. INTERNATIONAL JOURNAL ORAL MAXILLOFACIAL SURGERY. VOLUME 42: PAGES 830-834. NETHERLANDS. THIS ARTICLE FOLLOWED A (B)(6) WOMAN WHO UNDERWENT A SEGMENTAL MANDIBULECTOMY DUE TO A MULTICYSTIC AMELOBLASTOMA IN THE LEFT JAW. PRIMARY RECONSTRUCTION WAS PERFORMED WITH A PLATE (UNILOCK PLATE 2.4, ANGLED). COMPLICATIONS: THE PATIENT EXPERIENCED A TRAUMA WHICH CAUSED THE PLATE TO BREAK. PATIENT WAS REVISED WITH A SIMILAR PLATE AND RECOVERY WAS UNEVENTFUL. THIS REPORT IS FOR AN UNKNOWN UNILOCK PLATE 2.4, ANGLED. THIS REPORT IS FOR 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ABSTRACT IS ATTACHED TO THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235009 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention