BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3822824 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11517
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ALTMAN, G., GALLO, R., MOLINERO, K., MUFFLY, M., MASCARENHAS, L. (2011). MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR PROXIMAL HUMERUS FRACTURES: FUNCTIONAL RESULTS OF TREATMENT. AM J ORTHOP. 40(3):E40-E47. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. 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: MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR PROXIMAL HUMERUS FRACTURES: FUNCTIONAL RESULTS OF TREATMENT. ALTMAN, G., GALLO, R., MOLINERO, K., MUFFLY, M., MASCARENHAS, L. (2011). MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR PROXIMAL HUMERUS FRACTURES: FUNCTIONAL RESULTS OF TREATMENT. AM J ORTHOP. 40(3):E40-E47. TWENTY-ONE PATIENTS WERE TREATED WITH MIP FOR 2-, 3-, AND 4-PART PROXIMAL HUMERUS FRACTURES WERE TREATED BETWEEN JANUARY 2006 AND OCTOBER 2007 WITH THE SYNTHES LCP PROXIMAL HUMERUS PLATE. IN A 61 YEAR OLD FEMALE PATIENT, THE REDUCTION WORSENED DURING THE POSTOPERATIVE PERIOD AND REQUIRED HARDWARE REMOVAL AFTER FRACTURE HEALING. DURING HEALING, REDUCTION WAS LOST AND SHE DEVELOPED IMPINGEMENT. THE PLATE WAS REMOVED AFTER HEALING OF THE FRACTURE, BUT SIGNIFICANT FUNCTION LIMITATIONS PERSISTED OVER ONE YEAR. THIS REPORT IS 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
    303898 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention