BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PARALLEL CONNECTOR

    MDR report key: 2032594 · Received March 23, 2011

    Report

    Report Number
    2530088-2011-00076
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT IMPLANTED WITH BI-LATERAL VEPTR II ON (B)(6) 2010. PT HAD REGULAR LENGTHENING PROCEDURE INVOLVING PLACEMENT OF ONE RIB SLEEVE AND DISTRACTION LOCK ON (B)(6) 2011. STATUS POST, PT DEVELOPED INFECTION AND HARDWARE WAS EXPLANTED ON THE RIGHT SIDE RIB TO ILIUM ON (B)(6)2011. THIS IS THE 2ND OF 6 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI PARALLEL CONNECTOR VEPTR IMPLANT MDI SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention RIB HOOK| DISTAL EXTENSION| DISTRACTION LOCK| S-HOOK| PROXIMAL EXTENSION