BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06499

    MDR report key: 3371474 · Received September 26, 2013

    Report

    Report Number
    2520274-2013-06499
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    August 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER PROVIDED THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ENTITLED: NON-FUSION AND GROWING INSTRUMENTATION IN THE CORRECTION OF CONGENITAL SPINAL DEFORMITY ASSOCIATED WITH SPLIT SPINAL CORD MALFORMATION: AN EARLY FOLLOW-UP OUTCOME. HUI H., LUO Z.J., YAN M., YE Z.X., TAO H.R. AND WANG H.Q; EUROPEAN SPINE JOURNAL. REPORTED: A RETROSPECTIVE CASE REVIEW BETWEEN 2007 AND 2010 TO EVALUATE THE SAFETY AND EFFICACY OF THE NON-FUSION TECHNIQUE IN ACHIEVING AND MAINTAINING THE PROPER CORRECTION FOR CONGENITAL SPINAL DEFORMITY (CSD) AND ALLOWING NORMAL SPINAL GROWTH IN PATIENTS WITH SPLIT SPINAL CORD MALFORMATION (SSCM). THERE WERE SEVEN PATIENTS: SIX FEMALE AND ONE MALE PATIENT WITH A DIAGNOSIS OF CSD ASSOCIATED WITH SSCM AND A MEAN AGE OF 8 YEARS. ALL PATIENTS IN THIS STUDY RECEIVED HALO-GRAVITY TRACTION (HGT) PRIOR TO EXPANSION OF THE SPINE AND INSTRUMENTATION WITH VERTICAL EXPANDABLE TITANIUM PROSTHETIC RIB (VEPTR), GROWING ROD OR THEIR HYBRID. FIVE OF THE PATIENTS UNDERWENT OPENING WEDGE THORACOPLASTY SIMULTANEOUSLY. ALL PATIENTS WERE FOLLOWED UP WITH AN AVERAGE OF 32.6 MONTHS. THERE WERE NO COMPLICATIONS REPORTED FOR ANY OF THE PATIENTS REGARDING THE COURSE OF TRACTION AND ONLY THREE OF THE SEVEN PATIENTS EXPERIENCED COMPLICATIONS FROM THE SURGERY. THIS COMPLAINT REGARDS TWO PATIENTS WHO EXPERIENCED ASYMPTOMATIC PROXIMAL MIGRATION OF THE RIB CRADLE A TOTAL OF FOUR TIMES. THE FIRST PATIENT EXPERIENCED COMPLETE MIGRATION OF THE VEPTR RIB CRADLE THROUGH THE OSSEOUS RIB AT 1, 1.5 AND 2 YEARS AFTER IMPLANT SURGERY AND THE SECOND PATIENT EXPERIENCED COMPLETE MIGRATION 6 MONTHS AFTER SURGERY. ALL EVENTS OF MIGRATION WERE DIAGNOSED ON PREOPERATIVE RADIOGRAPHS OF SCHEDULED VEPTR EXPANSION PROCEDURES AND THE RIB CRADLES WERE RESEATED DURING THE SCHEDULED PROCEDURES. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487763 MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention