BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEPTR IMPLANT

    MDR report key: 1139547 · Received August 28, 2008

    Report

    Report Number
    2520274-2008-00063
    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 SEVERE PULMONARY DISEASE AND NEUROMUSCULAR SCOLIOSIS WITH AN UPPER RIGHT CURVE MEASURING 70 DEGREE AND A LOWER LEFT CURVE MEASURING 90 DEGREE WAS IMPLANTED WITH A RIB-TO-RIB AND A RIB-TO-SPINE VEPTR WITH A LEFT THORACOTOMY. POSTOPERATIVELY, THE PT DEVELOPED PLEURAL EFFUSION WHICH WAS DRAINED AND HAD A WOUND INFECTION OF THE RIB-TO-SPINE VEPTR THE RIB-TO-SPINE VEPTR WAS REMOVED, THE AREA I&D'D, IV ANTIBIOTICS WERE GIVEN, NUTRITIONAL SUPPORT WAS GIVEN AND A RIB-TO-SPINE VEPTR WAS REIMPLANTED SIX MONTHS LATER. THE PT NOW HAS A RIB-TO RIB VEPTR ON ONE SIDE AND A RIB-TO-SPINE VEPTR ON THE OTHER SIDE FOR CONTROL OF THE LUMBAR CURVE.

    Devices

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

    Patients

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