BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3780974 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11024
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. ¿PHILOS LOCKING PLATES IN PROXIMAL HUMERUS FRACTURES IN OSTEOPOROTIC PATIENTS.¿ GUPTA, P., AND SAHU, R. L. (2012, SEPTEMBER). INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND BIOLOGICAL SCIENCES FUNDAMENTALS, VOL. 02, ISSUE 01, ISSN: 2278-3997. THIS REPORT IS FOR UNKNOWN PHILOS SCREWS/UNKNOWN LOT. 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, ¿PHILOS LOCKING PLATES IN PROXIMAL HUMERUS FRACTURES IN OSTEOPOROTIC PATIENTS.¿ GUPTA, P., AND SAHU, R. L. (2012, SEPTEMBER). INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND BIOLOGICAL SCIENCES FUNDAMENTALS, VOL. 02, ISSUE 01, ISSN: 2278-3997. THIS WAS A PROSPECTIVE STUDY CONDUCTED BETWEEN JULY 2005 TO JULY 2008. A TOTAL OF 20 PATIENTS WITH PROXIMAL HUMERUS FRACTURE WERE INCLUDED IN THIS STUDY. ALL OF THEM UNDERWENT SURGICAL TREATMENT WITH PHILOS PLATE SYSTEM (SYNTHES STRATEC MEDICAL LTD., PHILADELPHIA, USA). PLATE WAS FIXED WITH SCREW AT LONGITUDINAL DYNAMIC HOLE. NO PATIENTS HAD AXILLARY NERVE PARESIS, WOUND INFECTION, VASCULAR INJURIES OR OSTEONECROSIS OF HEAD. LOOSENING OF IMPLANT WAS OBSERVED IN ONE PATIENT. HOWEVER, FRACTURE UNITED WITHOUT THE NEED OF REFIXATION. IT WAS CONCLUDED THAT THE PHILOS PLATE IS EFFECTIVE IN MAINTAINING FRACTURE REDUCTION IN PROXIMAL HUMERUS FRACTURES. DUE TO STABLE RESTORATION, EARLY FUNCTIONAL AFTERCARE IS POSSIBLE AND ALLOWS THE PATIENT TO REGAIN GOOD SHOULDER FUNCTION AND RETURN TO WORK EARLIER. LOSS OF REDUCTION IS RARE WITH PHILOS PLATE. THIS REPORT IS FOR UNKNOWN PHILOS SCREWS. THIS IS REPORT 2 OF 2 FOR COM-(B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259704 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1