BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4694770 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12899
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    April 8, 2009
    Report Date
    April 7, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN 4.5-MM LOCKING COMPRESSION PLATE (SYNTHES INC.), 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 JOURNAL ARTICLE, HAO, T., ET AL., (2009). "TREATMENT OF POSTERIOR PELVIC RING INJURIES WITH MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS." INTERNATIONAL ORTHOPAEDICS (SICOT), 33:1435-1439. FROM JANUARY 2004 TO JULY 2007, 21 PATIENTS WITH INJURIES AT THE POSTERIOR PELVIC RING WERE TREATED WITH LOCKING COMPRESSION PLATE (LCP) OSTEOSYNTHESIS THROUGH A MINIMALLY INVASIVE APPROACH AND FOLLOWED UP FOR A MEAN OF 12.2 MONTHS. A TOTAL OF 21 PATIENTS (16 MEN AND 5 WOMEN) RANGING IN AGE FROM 27 TO 59 YEARS (MEAN: 35.6 YEARS) WITH POSTERIOR PELVIC RING INJURIES WERE ADMITTED AND TREATED WITH THE LCP IN A TRAUMA CENTRE. PREOPERATIVE AND POSTOPERATIVE RADIOGRAPHY WAS CONDUCTED TO ASSESS THE REDUCTION AND UNION. A 4.5-MM LOCKING COMPRESSION PLATE (SYNTHES INC.) OF APPROPRIATE LENGTH (USUALLY 10-12 HOLES) WAS USED TO MAINTAIN THE REDUCTION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 4.5-MM LOCKING COMPRESSION PLATE (SYNTHES INC.) AND REFERS TO ONE CASE THAT REPORTED PAIN POSTOPERATIVELY, AND TWO CASES THAT EXPERIENCED LOSS OF REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250154 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention