BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEPTR IMPLANT

    MDR report key: 1139546 · Received August 28, 2008

    Report

    Report Number
    2520274-2008-00062
    Event Type
    Injury
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE THE MFR SITE OR THE MFR DATE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A PT WITH ARTHROGRYPOSIS HAD A RIB-TO-RIB AND A RIB-TO-SPINE VEPTR DEVICE IMPLANTED. A WOUND INFECTION DEVELOPED AFFECTING THE RIB-TO-RIB DEVICE AS IT WAS DIRECTLY BENEATH THE SKIN, THE RIB-TO-SPINE DEVICE WAS NOT INFECTED. POST-OPERATIVELY, THE PT HAD A CHEST TUBE PLACED FOR A PNEUMOTHORAX, WHICH OCCURRED WITH THE PLACEMENT OF THE DEVICE. THE RIB-TO-RIB DEVICE REQUIRED REMOVAL THREE WEEKS AFTER IMPLANT. THE PT HAD IV ANTIBIOTICS AND LOCAL WOUND CARE AND THE RIB-TO-RIB DEVICE WAS REPLACED SIX MONTHS LATER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEPTR IMPLANT VEPTR IMPLANT MDI SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LAMINA| HOOKS| RIB SLEEVES| CRADLES| EXTENSION| LOCK