BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03290

    MDR report key: 3161292 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03290
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    February 21, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH VEPTR ON AN UNSPECIFIED DATE. REPORTEDLY X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED THE SUPERIOR CRADLE OF THE VEPTR (RIGHT, HYBRID TYPE) WAS DISPLACED. ON (B)(6) 2012, THE SURGEON EXTRACTED ONE OF THE RIGHT HYBRID TYPE AND THE OTHER THREE WERE EXTENDED. THE SURGEON REPORTED THE PATIENTS RIB WAS VERY BRITTLE AND THE PATIENT COULD NOT DENY THE STRESS OF THE RIB BY THE IMPLANT. THIS REPORT IS FOR AN UNKNOWN VEPTR (RIGHT, HYBRID TYPE) IMPLANT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263080 MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention