BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3761784 · Received April 21, 2014

    Report

    Report Number
    2520274-2014-10921
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. VILALTA VIDAL, I., (2011), SCOLIOSIS IN IMPERFECT OSTEOGENESIS: IS VEPTR A TREATMENT OPTION?, EUROPEAN SPINE JOURNAL, 20:2067¿2095. DOI 10.1007/S00586-011-2013-1. THIS REPORT IS FOR AN UNKNOWN VEPTR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VILALTA VIDAL, I., (2011), SCOLIOSIS IN IMPERFECT OSTEOGENESIS: IS VEPTR A TREATMENT OPTION?, EUROPEAN SPINE JOURNAL, 20:2067¿2095. DOI 10.1007/S00586-011-2013-1. IMPERFECT OSTEOGENESIS IS AN OSTEOCHONDRODYSPLASIA CAUSED BY A MUTATION OF THE TYPE I COLLAGEN GENE. CLINICALLY, IT IS MANIFESTED BY MULTIPLE FRACTURES THAT PRODUCE SHORTENING, WITH DEFORMITIES AND SCOLIOSIS. IN THIS ABSTRACT PATIENTS WERE TREATED WITH A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) PRODUCT. THERE WERE THREE CASES PRESENTED, TWO GIRLS AND ONE BOY THEIR AGES IS NINE, SIX, AND FOUR YEARS AT SURGERY WITH SEVERE SCOLIOSIS. FOLLOW-UP WAS PERFORMED 18 MONTHS TO SIX YEARS. COMPLICATIONS INCLUDED PULL-OUT DUE RIB FRACTURE IN TWO PATIENTS, BOTH OCCURRING AFTER THE FIRST LENGTHENING AND REQUIRING A REOPERATION WITH NEW FIXATION. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241183 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention