BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4706563 · Received April 20, 2015

    Report

    Report Number
    2520274-2015-13148
    Event Type
    Injury
    Date Received
    April 20, 2015
    Report Date
    April 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HASENBOEHLER, E., RIKLI, D., BABST, R. LOCKING COMPRESSION PLATE WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS IN DIAPHYSEAL AND DISTAL TIBIAL FRACTURE: A RETROSPECTIVE STUDY OF 32 PATIENTS. INJURY, INT. J. CARE INJURED (2007) 38, 365-370. THIS REPORT IS FOR AN UNKNOWN 4.5 MM LCP AND 3.5 MM LCP-PILON PLATE (SYNTHES USA). 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: HASENBOEHLER, E., RIKLI, D., BABST, R. LOCKING COMPRESSION PLATE WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS IN DIAPHYSEAL AND DIATAL TIBIAL FRACTURE: A RETROSPECTIVE STUDY OF 32 PATIENTS. INJURY, INT. J. CARE INJURED (2007) 38, 365-370. WE RETROSPECTIVELY EVALUATED THE HEALING PATTERN AND THE CLINICAL EVOLUTION OF DIAPHYSEAL AND DISTAL TIBIAL SHAFT FRACTURES OVER TWO AND A HALF YEARS IN 32 PATIENTS (6 FEMALES, 26 MALES). FRACTURES WERE CLASSIFIED ACCORDING TO AO CLASSIFICATION AND INCLUDED ALL 42A-C, 43A-B AND 43C1-2 TYPES. FOR OPEN FRACTURES, GUSTILLO ANDERSON CLASSIFICATION WAS USED. PLATES CONSISTED OF THE (28) 4.5 MMLCP AND ( 4) 3.5 MMLCP-PILON FORM PLATE. CLINICAL AND RADIOLOGICAL ASSESSMENT WAS PERFORMED AT 6 WEEKS, AND AT 3, 6, 9, AND 12 MONTHS. TWO PATIENTS WERE LOST TO FOLLOW-UP. COMPLICATIONS: 1-DIED DUE TO A PRIMARY DISEASE, 1-PLATE BENDING AND CALLED FOR RE-OPERATION,DELAYED HEALING, 2-PATIENTS REQUIRED RE-OPERATION, DELAYED HEALING OR PSEUDARTHROSIS, THIS REPORT IS FOR AN UNKNOWN-4.5 MM LCP AND 3.5 MM LCP-PILON PLATE. THIS IS REPORT OF 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE SERIOUS INJURY OF 1 PATIENT THAT EXPERIENCED: PLATE BENDING AND CALLED FOR RE-OPERATION,DELAYED HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260288 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention