BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5893070 · Received August 22, 2016

    Report

    Report Number
    2520274-2016-14223
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    August 6, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: BARBIERI, C.H., MAZZER, N., ARANDA, C.A., DE O. PINTO, M.M. (1997). USE OF A BONE BLOCK GRAFT FROM THE ILIAC CREST WITH RIGID FIXATION TO CORRECT DIAPHYSEAL DEFECTS OF THE RADIUS AND ULNA. JOURNAL OF HAND SURGERY (BRITISH AND EUROPEAN VOLUME), VOLUME 22B, VERSION 3, PP. 395-401. BRAZIL. THIS REPORT IS FOR UNKNOWN 3.5MM DYNAMIC LOCKING PLATES, UNKNOWN QUANTITY, UNKNOWN LOT. PRODUCT CODE: HRS. UDI #: UNKNOWN PART NUMBER, UDI UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED. 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 LITERATURE ARTICLE: BARBIERI, C.H., MAZZER, N., ARANDA, C.A., DE O. PINTO, M.M. (1997). USE OF A BONE BLOCK GRAFT FROM THE ILIAC CREST WITH RIGID FIXATION TO CORRECT DIAPHYSEAL DEFECTS OF THE RADIUS AND ULNA. JOURNAL OF HAND SURGERY (BRITISH AND EUROPEAN VOLUME), VOLUME 22B, VERSION 3, PP. 395-401. BRAZIL. THE STUDY INCLUDED TWELVE PATIENTS (10 MALES, 2 FEMALES) WITH A MEAN AGE OF 29 YEARS (RANGE: 11-71 YEARS) WHO WERE OPERATED ON TO REPAIR DIAPHYSEAL DEFECTS OF THE RADIUS AND ULNA. THE PATIENTS WERE TREATED WITH A BONE BLOCK GRAFT FROM THE ILIAC CREST AND IMPLANTED WITH SYNTHES AO 3.5MM DYNAMIC COMPRESSION PLATES. THE FOLLOWING COMPLICATIONS WERE REPORTED: 1 PATIENT PRESENTED WITH GRAPH RESORPTION. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 3.5MM DYNAMIC LOCKING PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544944 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention