BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5866458 · Received August 10, 2016

    Report

    Report Number
    2520274-2016-14022
    Event Type
    Injury
    Date Received
    August 10, 2016
    Report Date
    July 25, 2016
    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. SCHLIEMANN, B AND ¿ET ALL¿. (2015). TREATMENT OF PROXIMAL HUMERUS FRACTURES WITH A CFR-PEEK PLATE: 2-YEAR RESULTS OF A PROSPECTIVE STUDY AND COMPARISON TO FIXATION WITH A CONVENTIONAL LOCKING PLATE. J SHOULDER ELBOW SURG, 24, 1282-1288. THIS REPORT IS FOR UNKNOWN (PHILOS) PLATE /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. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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 SCHLIEMANN, B AND 셔 ALL�(2015). TREATMENT OF PROXIMAL HUMERUS FRACTURES WITH A CFR-PEEK PLATE: 2-YEAR RESULTS OF A PROSPECTIVE STUDY AND COMPARISON TO FIXATION WITH A CONVENTIONAL LOCKING PLATE. J SHOULDER ELBOW SURG, 24, 1282-1288. THE AIM OF THIS STUDY WAS THEREFORE TO REPORT CLINICAL AND RADIOGRAPHIC RESULTS OF PATIENTS TREATED WITH A CARBON FIBER-REINFORCED POLYETHERETHERKETONE (CRF-PEEK) PLATE FOR A PROXIMAL HUMERUS FRACTURE. IN ADDITION, THE RESULTS WERE COMPARED WITH THOSE OF A PREVIOUS GROUP OF PATIENTS TREATED WITH A CONVENTIONAL LOCKING PLATE, AND THESE PATIENTS WERE MATCHED ON AGE, GENDER, AND FRACTURE TYPE. BETWEEN FEBRUARY 2012 AND APRIL 2013, 29 PATIENTS (22 WOMEN, 7 MEN) WERE TREATED WITH A CRF-PEEK PLATE (DIPHOS-H; LIMA CORPORATE, (B)(4)) FOR A PROXIMAL HUMERUS FRACTURE AND PROSPECTIVELY OBSERVED FOR 24 MONTHS. THE MEAN AGE OF THE PATIENTS AT TRAUMA WAS 66.4 YEARS (RANGE, 23-87 YEARS).THE HYPOTHESIS WAS THAT FIXATION WITH A (CFR-PEEK) PLATE PRODUCES OUTCOMES SIMILAR TO THOSE OF PATIENTS TREATED WITH CONVENTIONAL LOCKING PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN (PHILOS) PLATE AND REFERS TO FOLLOWING ADVERSE EVENTS: VARUS MAL-ALIGNMENT WAS OBSERVED IN 7 PATIENTS (24%) IN THE CONVENTIONAL LOCKING PLATE GROUP, WITH 4 PATIENTS PRESENTING WITH LOSS OF REDUCTION AFTER 6 WEEKS. IMPLANT REMOVAL WAS PERFORMED IN 8 PATIENTS (28%), (4 PATIENTS [14%] UNDERWENT ADDITIONAL ARTHROLYSIS). AVASCULAR NECROSIS OF THE HEAD FRAGMENT OR THE MAJOR TUBEROSITY WAS OBSERVED IN 3 PATIENTS (10%) IN THE CONVENTIONAL LOCKING PLATE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517859 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention