BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4688557 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12739
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    March 30, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE (ABSTRACT) RENGER, R.J. MD, "ET AL". THE CLAVICLE HOOK PLATE FOR NEER TYPE II LATERAL CLAVICLE FRACTURE. J ORTHOP TRAUMA 2009; 23:570-574. THIS REPORT IS FOR AN UNKNOWN CLAVICLE HOOK PLATE AND AO 3.5 MM CORTEX SCREWS/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 LITERATURE ARTICLE (ABSTRACT) RENGER, R.J. MD, "ET AL". THE CLAVICLE HOOK PLATE FOR NEER TYPE II LATERAL CLAVICLE FRACTURE. J ORTHOP TRAUMA 2009; 23:570-574. ((B)(6)). THIS WAS RETROSPECTIVE MULTI-CENTER STUDY ACROSS FIVE HOSPITALS. PATIENTS WITH A CLAVICLE FRACTURE, WHO WERE OPERATED IN THE PERIOD JANUARY 2003 TO DECEMBER 2006. PATIENTS WITH A NEER TYPE II CLAVICLE FRACTURE TREATED WITH THE CLAVICLE HOOK PLATE WERE INCLUDED IN THE STUDY. THE MEAN FOLLOW-UP PERIOD WAS 27.4 MONTHS (RANGE 13-48 MONTHS). THE STUDY GROUP CONSISTED OF 29 MEN AND 15 WOMEN, WITH AN AVERAGE AGE OF 38.4 YEARS(RANGE 18-66 YEARS). COMPLICATION: 1-DISLOCATION, 2 PSEUDARTHROSIS, 2 HYPERTROPHIC SCAR TISSUE AND 3 ACROMIAL OSTEOLYSIS, 33-REPORTED DISCOMFORT DUE TO IMPLANT. THIS REPORT IS FOR AN UNKNOWN CLAVICLE HOOK PLATE AND AO 3.5 MM CORTEX SCREWS. THIS IS REPORT OF 3 OF 4 FOR (B)(4). THIS REPORT IS FOR THE SERIOUS INJURY OF 41 PATIENTS THAT EXPERIENCE: 1-DISLOCATION, 2 PSEUDARTHROSIS, 2 HYPERTROPHIC SCAR TISSUE AND 3 ACROMIAL OSTEOLYSIS, 33-REPORTED DISCOMFORT DUE TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248022 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention