BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4241750 · Received November 10, 2014

    Report

    Report Number
    2520274-2014-14566
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ¿STAINLESS STEEL 2.0-MM LOCKING COMPRESSION PLATE OSTEOSYNTHESIS SYSTEM FOR THE FIXATION OF COMMINUTED HAND FRACTURES IN ASIAN ADULTS.¿ (2011) HING-CHEONG, W., HIN-KEUNG, W., AND KAM-YIU, W. JOURNAL OF ORTHOPAEDICS, TRAUMA AND REHABILITATION 15; 57-61. THIS REPORT IS FOR AN UNKNOWN LCP PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. FOR EXTENSOR TENOLYSIS. 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 JOURNAL ARTICLE, ¿STAINLESS STEEL 2.0-MM LOCKING COMPRESSION PLATE OSTEOSYNTHESIS SYSTEM FOR THE FIXATION OF COMMINUTED HAND FRACTURES IN ASIAN ADULTS.¿ (2011) HING-CHEONG, W., HIN-KEUNG, W., AND KAM-YIU, W. JOURNAL OF ORTHOPAEDICS, TRAUMA AND REHABILITATION 15; 57-61. THIS WAS A RETROSPECTIVE STUDY WAS TO ANALYZE THE CLINICAL OUTCOME OF THE APPLICATION OF STAINLESS STEEL 2.0-MM LOCKING COMPRESSION PLATE (LCP) SYSTEM FOR THE TREATMENT OF COMMINUTED HAND FRACTURES IN ASIAN ADULTS. SIX PATIENTS WHO HAD COMMINUTED HAND FRACTURES WERE TREATED BY OPEN REDUCTION AND INTERNAL FIXATION WITH THE APPLICATION OF STAINLESS STEEL 2.0-MM LCP (AO COMPACT HAND SYSTEM; SYNTHES, (B)(4)) FROM (B)(6) 2009 TO OCTOBER 2010. THE TOTAL ARC OF MOTION OF FINGERS, GRIP POWER, COMPLICATIONS, AND ADDITIONAL SURGERY WERE RECORDED. ALL THE FRACTURES HEALED UNEVENTFULLY WITHOUT IMPLANT FAILURE. A (B)(6) MALE EXPERIENCED 40 DEGREE FLEXION CONTRACTURE, AND IMPLANT IMPINGEMENT REQUIRING IMPLANT REMOVAL, AND EXTENSOR TENOLYSIS. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR UNKNOWN STAINLESS STEEL 2.0MM LCP PLATES. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723774 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention