BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5881962 · Received August 17, 2016

    Report

    Report Number
    2520274-2016-14155
    Event Type
    Injury
    Date Received
    August 17, 2016
    Report Date
    August 4, 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. SALMINEN, S., PIHLAJAMÄKI, H., VISURI, T. AND BÖSTMAN, O. (2003). DISPLACED FATIGUE FRACTURES OF THE FEMORAL SHAFT. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 409, 250¿259. THIS REPORT IS FOR AN UNKNOWN AO DYNAMIC COMPRESSION PLATE / UNKNOWN QUANTITY / UNKNOWN LOT. (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 WAS PROVIDED. 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 FOLLOWING LITERATURE ARTICLE, SALMINEN, S., PIHLAJAMċI, H., VISURI, T. AND BOSTMAN, O. (2003). DISPLACED FATIGUE FRACTURES OF THE FEMORAL SHAFT. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 409, 250-259. THE AUTHORS ANALYZED ALL DISPLACED FATIGUE FRACTURES OF THE FEMORAL SHAFT WHICH WERE TREATED DURING A 20-YEAR PERIOD AT A NATIONAL MILITARY HOSPITAL. TREATMENT INCLUDED INTRAMEDULLARY NAIL, DYNAMIC CONDYLAR SCREW-PLATE AND ASSOCIATION FOR OSTEOSYNTHESIS (AO) DYNAMIC COMPRESSION PLATE. TEN PREVIOUSLY HEALTHY MALE RECRUITS SUSTAINED DISPLACED FEMORAL SHAFT FATIGUE FRACTURES. THE MEDIAN AGE OF THE PATIENTS WAS 19 YEARS (RANGE, 18-20 YEARS). MEDIAN BODY MASS INDEX WAS NORMAL. FOUR MEN SMOKED. THE MEDIAN FOLLOW-UP WAS SEVEN YEARS (RANGE, 2-16 YEARS). RESULTS INCLUDED PATIENT 7, A (B)(6) YEAR-OLD PREVIOUSLY HEALTHY MALE WHO SUSTAINED A DISPLACED SPIRAL FATIGUE FRACTURE. A SLIGHT COMMINUTION WAS DETECTABLE ON THE LATERAL RADIOGRAPH. THE FRACTURE WAS STABILIZED WITH AN AO DYNAMIC COMPRESSION PLATE. THE PLATING RESULTED IN AN INCREASED COMMINUTION OF THE FRACTURE THAT NECESSITATED ADDITIONAL LAG SCREW FIXATION. SOLID BONY UNION WAS SEEN THREE MONTHS POSTOPERATIVELY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO DYNAMIC COMPRESSION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534734 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention