BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DISTRACTION LOCK

    MDR report key: 2483080 · Received March 2, 2012

    Report

    Report Number
    2530088-2012-00126
    Event Type
    Injury
    Date Received
    March 2, 2012
    Report Date
    February 20, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MFG DAE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH VEPTR I ON LEFT AND RIGHT SIDE OF SPINE SEVERAL YEARS AGO. IMPLANT ON RIGHT SIDE BECAME DISLODGED. SURGEON BELIEVES THE LAST LENGTHENING MAY HAVE CAUSED THE IMPLANT TO DISLODGE. THE RIGHT SIDE VEPTR WAS REMOVED AND REPLACED WITH VEPTR II ON (B)(6), 2012. LEFT SIDE OF VEPTR I REMAINED IMPLANTED IN THE PT. THIS IS THE 1ST OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI DISTRACTION LOCK DISTRACTION LOCK MDI SYNTHES BRANDYWINE 5415474

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention LUMBAR EXTENSION| RIB SLEEVE