BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5038277 · Received August 28, 2015

    Report

    Report Number
    2520274-2015-15453
    Event Type
    Injury
    Date Received
    August 28, 2015
    Report Date
    August 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ABSTRACT IS LISTED AS FM44, AND CAN BE FOUND ON PAGE 14S. THIS REPORT IS FOR AN UNKNOWN 3.5MM LCDCP PLATE AND AN UNKNOWN 2.7MM LCP PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. 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 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). IN GROUP 1 THERE WAS PAIN AT THE PLATE SITE IN 29 PATIENTS, REMOVAL OF THE PLATE IN 28 PATIENTS, 22 WERE DUE TO PAIN AND 3 IN ADDITION TO OTHER SURGERIES. THERE WAS ONE COMPLICATION OF COMPARTMENT SYNDROME, ONE OF COMPLEX REGIONAL PAIN SYNDROME. IN GROUP 2, 18 PATIENTS EXPERIENCED PAIN, PLATE REMOVAL IN 13 PATIENTS, 2 IN CONJUNCTION WITH OTHER SURGERIES. THERE WAS A COMPLICATION OF TRAUMATIC AVULSION OF THE PLATE, REPEAT PLATE FIXATION. THERE WERE SEVEN INSTANCES OF COMPLEX REGIONAL PAIN SYNDROME. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5MM LCDCP PLATE AND AN UNKNOWN 2.7MM LCP PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572036 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention