BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3873021 · Received June 13, 2014

    Report

    Report Number
    2520274-2014-11781
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 5, 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. WU, C., ET. AL., (2011), LOCKED PLATING FOR PROXIMAL HUMERAL FRACTURES: DIFFERENCES BETWEEN THE DELTOPECTORAL AND DELTOID-SPLITTING APPROACHES, THE JOURNAL OF TRAUMA INJURY INFECTION AND CRITICAL CARE, 71, 1364-1370. THIS REPORT IS FOR AN UNKNOWN SCREW. 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: WU, C., ET. AL., (2011), LOCKED PLATING FOR PROXIMAL HUMERAL FRACTURES: DIFFERENCES BETWEEN THE DELTOPECTORAL AND DELTOID-SPLITTING APPROACHES, THE JOURNAL OF TRAUMA INJURY INFECTION AND CRITICAL CARE, 71, 1364-1370. LOCKING PROXIMAL HUMERUS PLATE (LPHP) FIXATION HAS RECENTLY BECOME AVAILABLE FOR THE TREATMENT OF PROXIMAL HUMERAL FRACTURES. BETWEEN APRIL 2004 AND OCTOBER 2007, 63 CONSECUTIVE PATIENTS WITH DISPLACED PROXIMAL HUMERAL FRACTURES WHO UNDERWENT LPHP OSTEOSYNTHESIS IN OUR INSTITUTE WERE CLASSIFIED TO TWO TREATMENT GROUPS RETROSPECTIVELY: THE DELTOPECTORAL INCISION AND THE DELTOID-SPLITTING INCISION ACCORDING TO SURGEON¿S PREFERENCE. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS WITH REGARD TO DEMOGRAPHIC DATA, PREOPERATIVE RADIOGRAPHIC FINDINGS, AND DURATION OF FOLLOW-UP. RADIOGRAPHS WERE TAKEN PREOPERATIVELY, IMMEDIATELY POSTOPERATIVELY, 6 WEEKS, 3 MONTHS, 6 MONTHS, AND 1 YEAR POSTOPERATIVELY, AND ANNUALLY THEREAFTER. THE COMPLICATIONS NOTED ARE ONE PATIENT THAT HAD A DEEP WOUND INFECTION REQUIRING SURGICAL DEBRIDEMENT, NON-UNIONS, AVASCULAR NECROSIS, AND INTRA-ARTICULAR SCREW PENETRATION. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349456 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention