BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4689745 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12713
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    March 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LAFLAMME, G. ET AL (2008). PERCUTANEOUS HUMERAL PLATING OF FRACTURES OF THE PROXIMAL HUMERUS: RESULTS OF A PROSPECTIVE MULTICENTER CLINICAL TRIAL. J ORTHOP TRAUMA, 22, 153-158. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4) MALALIGNMENT. 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, LAFLAMME, G. ET AL (2008). PERCUTANEOUS HUMERAL PLATING OF FRACTURES OF THE PROXIMAL HUMERUS: RESULTS OF A PROSPECTIVE MULTICENTER CLINICAL TRIAL. J ORTHOP TRAUMA, 22, 153-158. THE AUTHORS CONDUCTED A PROSPECTIVE MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND FUNCTIONAL OUTCOME OF PERCUTANEOUS PLATING FOR PROXIMAL HUMERUS FRACTURES USING A PROXIMAL HUMERUS SPECIFIC LOCKING DEVICE, THE SYNTHES FIVE HOLE 3.5 MILLIMETER LOCKING COMPRESSION PLATE. A SPECIFIC TECHNIQUE WAS INVOLVED, USING TWO MINIMAL INCISIONS WITH A LATERAL DELTOID SPLIT AND A MORE DISTAL SHAFT INCISION. FROM FEBRUARY 2002 TO DECEMBER 2003, 34 PATIENTS WERE TREATED: 22 FEMALE, 12 MALE; MEAN AGE WAS 64 YEARS (RANGE, 38-88 YEARS). FOLLOW-UP WAS CONDUCTED TO STUDY THE FUNCTIONAL AND RADIOLOGIC OUTCOMES. TWENTY SEVEN PATIENTS WERE FOLLOWED FOR A MINIMUM OF 12 MONTHS, ON AN AVERAGE OF 19 MONTHS (RANGE, 12-34 MONTHS). SEVEN PATIENTS COULD NOT BE FOLLOWED FOR A MINIMUM OF ONE YEAR; ONE PATIENT DIED FROM UNRELATED CAUSES. RESULTS INCLUDED: ONE PLATE REMOVAL FOR ACROMIAL IMPINGEMENT AT EXTREME ABDUCTION. TWO FRACTURES HEALED WITH MORE THAN 20 DEGREES OF MALALIGNMENT. ALL FRACTURES HEALED WITHIN THE FIRST SIX MONTHS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247704 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention