BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

    MDR report key: 3981167 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12563
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    December 12, 2009
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. GAVASKAR, A., MUTHMUKUMAR, S., CHOWDARY, N., (2010), BIOLOGICAL OSTEOSYNTHESIS OF COMPLEX PROXIMAL HUMERUS FRACTURES: SURGICAL TECHNIQUE AND RESULTS FROM A PROSPECTIVE SINGLE CENTER TRIAL, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 130, 667-672. THIS REPORT IS FOR AN UNKNOWN PHILOS SYSTEM. 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: GAVASKAR, A., MUTHMUKUMAR, S., CHOWDARY, N., (2010), BIOLOGICAL OSTEOSYNTHESIS OF COMPLEX PROXIMAL HUMERUS FRACTURES: SURGICAL TECHNIQUE AND RESULTS FROM A PROSPECTIVE SINGLE CENTER TRIAL, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 130, 667-672. LOCKED PLATING FOR COMPLEX PROXIMAL HUMERUS FRACTURES THROUGH A DELTOPECTORAL INCISION CAN BE DIFFICULT DUE TO THE FRACTURE MORPHOLOGY AND NEED FOR FIXED ANGLE SCREWS. FIFTEEN PATIENTS WITH A DISPLACED THREE OR FOUR PART FRACTURE OF THE PROXIMAL HUMERUS WERE TREATED AT OUR INSTITUTION FROM JANUARY 2007 TO NOVEMBER 2007 USING MINI-INVASIVE LOCKED PLATING THROUGH TWO SMALL LATERAL TRANS-DELTOID INCISIONS. IN ADDITION TO THE PHILOS SYSTEM THERE WAS A COMPETITOR LOCKING PLATE USED THEREFORE THE ADVERSE EVENTS LISTED CANNOT BE DISASSOCIATED FROM THE DEVICES. THIS REPORT IS FOR A (B)(6) MALE PATIENT. ALL FRACTURES UNITED AT A MEAN OF 9 WEEKS. THE ABSENCE OF TENDERNESS ON PALPATION AND PRESENCE OF BRIDGING BONE ON RADIOGRAPHS WERE TAKEN AS DEFINITIVE EVIDENCE OF UNION. FRACTURE REDUCTION WAS DEEMED ANATOMICAL IN 12 PATIENTS IN THE IMMEDIATE POSTOPERATIVE X-RAYS. REDUCTION WAS NON-ANATOMICAL IN THREE PATIENTS. ONE PATIENT HAD A VALGUS MALALIGNMENT OF 10 DEGREE AND TWO PATIENTS HAD VARUS MALALIGNMENT OF 15 DEGREE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES AN UNKNOWN PHILOS SYSTEM FOR VARUS MALREDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458033 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT KTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention