BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-00705

    MDR report key: 3638021 · Received February 20, 2014

    Report

    Report Number
    2520274-2014-00705
    Event Type
    Injury
    Date Received
    February 20, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2011) 97, 622¿628. DEVICE IS AN UNKNOWN SCREW, QUANTITY 1. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: PERIPROSTHETIC FEMORAL FRACTURES TREATED BY LOCKED PLATING: FEASIBILITY ASSESSMENT OF THE MINI-INVASIVE SURGICAL OPTION. A PROSPECTIVE SERIES OF 36 FRACTURES; M. EHLINGER, P. ADAM, A. DI MARCO, Y. ARLETTAZ, B.-K. MOOR, F. BONNOMET; ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2011) 97, 622¿628; REPORTED: A FEASIBILITY ASSESSMENT OF THE MINI-INVASIVE SURGICAL APPROACH TO DEMONSTRATE FIXATION WITHOUT SUBSTANTIAL MISALIGNMENT OR NON-UNION OF PERIPROSTHETIC FEMORAL FRACTURES. RESULTS WERE BASED UPON A COHORT OF 30 PATIENTS, MEAN AGE 76 YEARS, WITH A TOTAL OF 31 FRACTURES, FROM 2002 TO 2007. THE MEAN FOLLOW-UP WAS 26 MONTHS. INTERNAL FIXATION WAS ATTEMPTED BY MINI-INVASIVE SURGERY USING LOCKING PLATE SYSTEM WITH LOCKING SCREWS (SYNTHES DEVICES). RESULTS INCLUDED: ONE CASE OF NONUNION IN WHICH PSEUDARTHROSIS WAS CONFIRMED VIA COMPUTED TOMOGRAPHY SCAN (NO TREATMENT WAS INSTITUTED DUE TO PATIENT CONDITION AND COMORBIDITIES); FIVE PATIENTS WITH MISALIGNMENT BY MORE THAN FIVE DEGREES; TWO INFECTIONS (TREATMENT INCLUDED ANTIBIOTICS AND SURGICAL DRAINING); TWO GENERAL CARDIOPULMONARY COMPLICATIONS (CARDIAC DECOMPENSATION AND PNEUMOPATHY); AND THREE MECHANICAL COMPLICATIONS (TWO CASES OF FIXATION LOSS AND ONE CASE OF PLATE BREAKAGE; TREATMENT INCLUDED REVISION IN TWO CASES). THE AUTHORS CONCLUDED THAT LOCKING COMPRESSION PLATES ASSOCIATED WITH A MINI-INVASIVE SURGICAL APPROACH RESULT IN A LOW RATE OF MECHANICAL FAILURE, A HIGH RATE OF UNION WITH NO SIGNIFICANT MISALIGNMENT AND NO REFRACTURES. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108341 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention