BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5884051 · Received August 17, 2016

    Report

    Report Number
    2520274-2016-14173
    Event Type
    Injury
    Date Received
    August 17, 2016
    Report Date
    August 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS DATE OF EVENT: M. WENZL ET AL., DELAYED AND NON-UNION OF THE HUMERAL DIAPHYSIS COMPRESSION PLATE OR INTERNAL PLATE FIXATOR? INJURY, INT. J. CARE INJURED (2004) 35, 55¿60. GERMANY. THIS REPORT IS FOR AN UNKNOWN LOW -CONTACT DYNAMIC COMPRESSION PLATE. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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 M. WENZL ET AL., DELAYED AND NON-UNION OF THE HUMERAL DIAPHYSIS COMPRESSION PLATE OR INTERNAL PLATE FIXATOR? INJURY, INT. J. CARE INJURED (2004) 35, 55¿60. GERMANY IN A RETROSPECTIVE STUDY, TWO GROUPS OF PATIENTS WITH DELAYED OR NON-UNION OF THE HUMERAL DIAPHYSIS WERE COMPARED. IN GROUP A, A 4.5-MM LOW-CONTACT DYNAMIC COMPRESSION PLATE (LCDCP) SYNTHES WAS USED FOR INTERNAL FIXATION AND IN GROUP B, AN INTERNAL PLATE FIXATOR WITH LOCKED SCREWS WAS USED. IN ALL PATIENTS AUTOLOGOUS BONE GRAFTING WAS PERFORMED. THERE WERE 14 PEOPLE IN GROUP A WITH A MEAN AGE OF 38.9 YEARS. GROUP B HAD 19 PATIENTS WITH THE MEAN AGE OF 54.3 YEARS. X-RAYS ON A (B)(6) PATIENT WITH A CLOSED FRACTURE OF THE HUMERAL SHAFT. APPROX 7 MONTHS AFTER THE TRAUMA IT WAS NOTED THE IMPLANTS WERE LOOSENING. THE IMPLANTS WERE REMOVED AND REVISED TO AN INTERNAL FIXATOR AND AUTOLOGOUS BONE GRAFTING THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR LOW -CONTACT DYNAMIC COMPRESSION PLATE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535622 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention