BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION BONE

    MDR report key: 3822933 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11524
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 26, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TYLLIANAKIS, M., PANAGOPOULOUS, A., SARIDIS, A. (2011) LONG-TERM RESULTS OF DORSALLY DISPLACED DISTAL RADIUS FRACTURES TREATED WITH THE PI-PLATE: IS HARDWARE REMOVAL NECESSARY? ORTHOPEDICS 34(7):E282-E286. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE: LONG-TERM RESULTS OF DORSALLY DISPLACED DISTAL RADIUS FRACTURES TREATED WITH THE PI-PLATE: IS HARDWARE REMOVAL NECESSARY? TYLLIANAKIS, M., PANAGOPOULOUS, A., SARIDIS, A. (2011) LONG-TERM RESULTS OF DORSALLY DISPLACED DISTAL RADIUS FRACTURES TREATED WITH THE PI-PLATE: IS HARDWARE REMOVAL NECESSARY? ORTHOPEDICS 34(7):E282-E286. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE OUTCOME OF PATIENTS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) USING DORSAL PLATES AND SCREWS (AO/ASIF PI-PLATE) FOR DORSALLY DISPLACED FRACTURES OF THE DISTAL RADIUS. THIRTY-TWO COMPLETELY EVALUATED PATIENTS (13 MEN AND 19 WOMEN; AVERAGE AGE 46 YEARS) IN THE DEPARTMENT OF UPPER LIMB SURGERY AND RECONSTRUCTION, ORTHOPEDIC CLINIC OF (B)(6) HOSPITAL,(B)(6) BETWEEN 2000 AND 2004. TWO PATIENTS WERE REOPERATED 6 WEEKS POSTOPERATIVELY DUE TO WRIST STIFFNESS ATTRIBUTED TO MATERIAL PROTRUSION INTO THE JOINT. SIX PATIENTS REPORTED DORSAL WRIST PAIN. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN DORSAL PI PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301388 PLATE, FIXATION BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention