BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LUMBAR EXTENSION SIZE 12/220MM RADIUS

    MDR report key: 2033483 · Received March 23, 2011

    Report

    Report Number
    2530088-2011-00074
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    February 21, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. IMPLANT DATE WAS APPROX 6 YEARS PRIOR TO EXPLANT DATE. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED 6 YEARS AGO WITH VEPTR I - RIB TO SPINE GROWING CONSTRUCT. F/U X-RAYS SHOWED THE ROD TO BE BROKEN ADJACENT TO THE SLEEVE. THE CONSTRUCT WAS EXPLANTED ON (B)(6) 2011 AND PT WAS REVISED TO VEPTR II. DEVICE IS UNAVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LUMBAR EXTENSION SIZE 12/220MM RADIUS VEPTR IMPLANT MDI SYNTHES BRANDYWINE NA 4833050

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SLEEVE