BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4608332 · Received March 17, 2015

    Report

    Report Number
    2520274-2015-11742
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    January 13, 2007
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORT IS FOR AN UNKNOWN HOOK-PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS 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, MURAMATSU, K., SHIGETOMI, M., MATSUNAGA, T., MURATA, Y. AND TAGUCHI, T. (2007). USE OF THE AO HOOK-PLATE FOR TREATMENT OF UNSTABLE FRACTURES OF THE DISTAL CLAVICLE. ARCH ORTHOP TRAUMA SURG, 127, 191-194. THE AUTHORS REPORTED THE OPERATIVE PROCEDURE AND CLINICAL RESULTS OBTAINED WITH THE USE OF THE INTERNAL FIXATIVE IMPLANT, THE ARBEITSGEMEINSCHAFT FÜR OSTEOSYNTHESEFRAGEN (AO) CLAVICLE HOOK-PLATE, FOR THE TREATMENT OF DISTAL CLAVICLE UNSTABLE FRACTURES. FIFTEEN PATIENTS, 13 MALES AND TWO FEMALES WITH AN AVERAGE AGE OF 47 YEARS (RANGE 20-71), WERE TREATED FROM JUNE 2003 TO OCTOBER 2004. MEAN FOLLOW-UP PERIOD WAS 15.5 MONTHS. ASSESSMENT TOOLS INCLUDED PLAIN RADIOGRAPHS AND FUNCTIONAL SHOULDER RECOVERY. RESULTS INCLUDED: HOOK MIGRATION INTO THE ACROMION OF 13 PATIENTS. TWELVE CASES UNDERWENT REMOVAL OF THE HOOK PLATE; ONE PATIENT REFUSED REMOVAL OF THE IMPLANT. ALL FRACTURES EVENTUALLY ACHIEVED BONY UNION WITHIN FOUR MONTHS AFTER SURGERY. CLINICAL RESULTS WERE REPORTED AS: EXCELLENT. THIS IS REPORT 9 OF 13 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN HOOK-PLATE AND REFERS TO SERIOUS INJURY/REPORTABLE MALFUNCTION IN CASE 10, A 38 YEAR OLD FEMALE WHO EXPERIENCED BENDING OF THE HOOK PLATE AND MILD HOOK MIGRATION. IMPLANT WAS REMOVED AT FIVE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180920 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention