BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3973425 · Received August 1, 2014

    Report

    Report Number
    2520274-2014-12645
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. QUALITY OF LIFE AND FUNCTIONAL OUTCOME AFTER A 2-PART PROXIMAL HUMERAL FRACTURE: A PROSPECTIVE COHORT STUDY ON 50 PATIENTS TREATED WITH A LOCKING PLATE. OLERUD, PER; AHRENGART, LEIF, SODERQVIST, ANITA, SAVING, JENNY; TIDERMARK, JAN. 2010 , JOURNAL OF SHOULDER AND ELBOW SURGERY BOARD OF TRUSTEES, 19, 814-822. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN QUANTITY/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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE. QUALITY OF LIFE AND FUNCTIONAL OUTCOME AFTER A 2-PART PROXIMAL HUMERAL FRACTURE: A PROSPECTIVE COHORT STUDY ON 50 PATIENTS TREATED WITH A LOCKING PLATE. OLERUD, PER; AHRENGART, LEIF, SODERQVIST, ANITA, SAVING, JENNY; TIDERMARK, JAN. 2010 , JOURNAL OF SHOULDER AND ELBOW SURGERY BOARD OF TRUSTEES, 19, 814-822. THIS IS A PROSPECTIVE COHORT STUDY WITH A 2-YEAR FOLLOW-UP, ON 50 PATIENTS WITH AN ACUTE DISPLACED 2-PART FRACTURE OF THE SURGICAL NECK OF THE HUMERUS, ACCORDING TO THE CLASSIFICATION OF NEER, TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION WITH A LOCKING PLATE BETWEEN JUNE 2003 AND FEBRUARY 2007. THE PHILOS PLATE (SYNTHES, (B)(4)) WAS USED IN ALL PATIENTS. IN TOTAL, 8 PATIENTS WERE RE-OPERATED DURING THE 2-YEAR FOLLOW-UP PERIOD. REOPERATIONS DUE TO A SUBOPTIMAL POSITION OF THE IMPLANT WERE PERFORMED IN 3 PATIENTS (TWO WITH PRIMARY SCREW PENETRATION AND 1 WITH IMPINGEMENT PROBLEMS). REOPERATIONS DUE TO SECONDARY DISPLACEMENT WERE PERFORMED ON 3 PATIENTS (2 WITH SECONDARY SCREW PENETRATION DUE TO MINOR RE-DISLOCATIONS AND 1 WITH A MAJOR REDISLOCATION). REVISION SURGERY DUE TO NONUNION WAS PERFORMED IN 1 PATIENT AND ONE PATIENT HAD A DEEP INFECTION AND UNDERWENT REPEATED WOUND REVISIONS AND LAVAGE. THIS REPORT IS 2 OF 3 FOR (B)(4). THIS REPORT REFERS TO AN UNKNOWN SCREW - PRIMARY/SECONDARY SCREW PENETRATION AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451169 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention