BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3931237 · Received July 14, 2014

    Report

    Report Number
    2520274-2014-12367
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    October 21, 2010
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SHI, H., ET AL (2011). MANAGEMENT OF PROXIMAL HUMERAL FRACTURES IN ELDERLY PATIENTS WITH UNI- OR POLYAXIAL LOCKING OSTEOSYNTHESIS SYSTEM. ARCH ORTHOP TRAUMA SURG, 131, 541-547. THIS REPORT IS FOR AN UNKNOWN PHILOS PLATE. (B)(6). 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, SHI, H., ET AL (2011). MANAGEMENT OF PROXIMAL HUMERAL FRACTURES IN ELDERLY PATIENTS WITH UNI- OR POLYAXIAL LOCKING OSTEOSYNTHESIS SYSTEM. ARCH ORTHOP TRAUMA SURG, 131, 541-547. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY TO EVALUATE THE CLINICAL EFFICACY OF UNI- AND POLYAXIAL LOCKING OSTEOSYNTHESIS SYSTEMS IN THE MANAGEMENT OF PROXIMAL HUMERAL FRACTURES IN ELDERLY PATIENTS; 76 CASES (28 MEN, 48 WOMEN, MEAN AGE 68.8 YEARS) WERE REVIEWED INCLUDING 18 CASES OF TWO-PART (NEER CLASSIFICATION), 36 CASES OF THREE-PART, AND 22 CASES OF FOUR-PART FRACTURES. ALL THE PATIENTS RECEIVED OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING OSTEOSYNTHESIS SYSTEM (PHILOS) OR A POLYAXIAL LOCKING OSTEOSYNTHESIS SYSTEM OF A COMPETITOR (NUMELOCK) BETWEEN MAY 2007 AND APRIL 2009. FORTY-THREE PATIENTS (15 MALE, 28 FEMALE) WERE ASSIGNED TO THE PHILOS-TREATED GROUP AND 33 PATIENTS (13 MALE, 20 FEMALE) WERE ASSIGNED TO THE NUMELOCK-TREATED GROUP. ALL THE FRACTURES WERE HEALED BY 3 MONTHS POSTOPERATIVELY JUDGING FROM CLINICAL AND RADIOLOGICAL EVALUATIONS. NO NERVE INJURIES, VASCULAR INJURIES, OR WOUND INFECTION OCCURRED DURING THE SURGERY OR IN THE EARLY POSTOPERATIVE PERIOD. OF THE 70 PATIENTS THAT FINISHED 12 MONTHS OF FOLLOW-UP, 65 ACHIEVED UNEVENTFUL FRACTURE HEALING WITHOUT LOSS OF REDUCTION, IMPLANT DISLOCATION, OR SCREW CUT-OUT. TWO PATIENTS (ONE (B)(6) AND ONE (B)(6)) IN THE PHILOS GROUP DEVELOPED VARUS MALUNION. PARTIAL AVASCULAR NECROSIS WAS OBSERVED IN ONE CASE (A (B)(6) PATIENT FROM THE PHILOS GROUP, THREE-PART FRACTURE) AT 12 MONTHS POSTOPERATIVELY, WHILE NO REVISION SURGERY OR HEMIARTHROPLASTY WAS CONSIDERED DUE TO MILD SYMPTOMS. THE AUTHORS CONCLUDED THAT BOTH OF THE PHILOS AND NUMELOCK SYSTEMS SHOWED EQUALLY GOOD RESULTS CONSIDERING FIXATION STABILITY AND FUNCTIONAL OUTCOMES OF PROXIMAL HUMERAL FRACTURES IN ELDERLY PATIENTS. THIS REPORT IS FOR AN UNKNOWN PHILOS PLATE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410860 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention