BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMON NAME PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3776224 · Received April 28, 2014

    Report

    Report Number
    2520274-2014-11043
    Event Type
    Injury
    Date Received
    April 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 23RD CONGRESS OF THE EUROPEAN SOCIETY FOR PEDIATRIC NEUROSURGERY (ESPN), AMSTERDAM-THE NETHERLANDS, 1¿5 MAY 2012. OP-70; PHILIP KUNKEL, RALF STUECKER (HAMBURG, GERMANY). CHILDS NERV SYST (2012) 28:775¿776. THIS REPORT IS FOR UNKNOWN VEPTR CONSTRUCT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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. 23RD CONGRESS OF THE EUROPEAN SOCIETY FOR PEDIATRIC NEUROSURGERY (ESPN), AMSTERDAM-THE NETHERLANDS, 1¿5 MAY 2012. OP-70; PHILIP KUNKEL, RALF STUECKER (HAMBURG, GERMANY). CHILDS NERV SYST (2012) 28:775¿776. THIS CASE WAS PRESENTED IN THE CONGRESS OF EUROPEAN SOCIETY OF PEDIATRIC NEUROSURGERY. IN A 5 YEARS PERIOD SIX CHILDREN WITH SPINA BIFIDA AND GIBBUS DEFORMITY WERE TREATED BY IMPLANTATION OF BILATERAL VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) CLAMPED BETWEEN THE UPPER RIBS AND THE POSTERIOR ILIAC CREST. MEAN AGE AT IMPLANTATION SURGERY WAS 6.6 YEARS (RANGE: 4.8- 9.5 YEARS). MEAN FOLLOW-UP PERIOD WAS 27.6 MONTHS (RANGE: 14¿ 61 MONTHS). A MEAN NUMBER OF 4.5 SURGERIES PER CHILD WERE CARRIED OUT (TOTAL NUMBER: 27). IN ONE CASE A VEPTR IMPLANT HAD TO BE TEMPORARILY REMOVED BECAUSE OF DEEP WOUND INFECTION. IN 25% OF ALL SCHEDULED LENGTHENING PROCEDURES, IMPLANT REVISIONS (MIGRATED, BROKEN OR UNDERSIZED IMPLANTS) HAD TO BE COMPLEMENTED. MEAN DISTRACTED LENGTH OF THE DEVICES WAS 2.9 CM (RANGE: 2¿6 CM). IN ONE BOY VEPTR TREATMENT LASTED FOR 5 YEARS. AT THE AGE OF 14.5 YEARS, AFTER GROWTH COMPLETION WAS ACHIEVED, HE RECEIVED A LIMITED KYPHECTOMY AND POSTERIOR SPINAL FUSION. THIS REPORT IS FOR UNKNOWN VEPTR CONSTRUCT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4) FOR IMPLANT REMOVAL BECAUSE OF DEEP WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254879 COMMON NAME PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1