BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5038284 · Received August 28, 2015

    Report

    Report Number
    2520274-2015-15457
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Report Date
    August 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    JUNGWIRTH, A., NAGY, L., SCHWEIZER, A., AND BORBAS, P. (2014) INFLUENCE OF PLATE SIZE AND DESIGN UPON HEALING OF ULNA SHORTENING OSTEOTOMIES. SWISS MEDICAL WEEKLY. 144 (SUPPL 204), 14S. THIS REFERS TO AN UNKNOWN 3.5MM LCDCP PLATE AND AN UNKNOWN 2.7MM LCP PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEICE 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 ABSTRACT: JUNGWIRTH, A., NAGY, L., SCHWEIZER, A., AND BORBAS, P. (2014) INFLUENCE OF PLATE SIZE AND DESIGN UPON HEALING OF ULNA SHORTENING OSTEOTOMIES. SWISS MEDICAL WEEKLY. 144 (SUPPL 204), 14S. THIS REFERS TO A COMPARATIVE STUDY OF 129 PATIENTS TREATED WITH ULNA SHORTENING OSTEOTOMIES (UOT) FROM 03/03 THROUGH 08/12. TREATMENT WAS WITH A 5 OR 6 HOLE 3.5MM LCDCP PLATE IN 75 PATIENTS BETWEEN 03/03 AND 05/1075 (GROUP 1). THE 2.7MM LCP PLATE WAS USED BEGINNING IN 07/10 IN 55 PATIENTS (GROUP 2). THERE WAS ONE INSTANCE OF PLATE LOOSENING NOTED IN GROUP 1. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5MM LCDCP PLATE AND AN UNKNOWN 2.7MM LCP PLATE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THE MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572038 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1