BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3768156 · Received April 23, 2014

    Report

    Report Number
    2520274-2014-11003
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT OPERATION 2.4 YEARS. ARTICLE PUBLISHED; APRIL 2011. EXACT DATE UNKNOWN. THIS REPORT FOR 1 UNKNOWN VEPTR, UNKNOWN PART#/LOT#. JEAN-FRANCOIS ET AL (2011, APRIL). HALO-GRAVITY TRACTION VERSUS SURGICAL RELEASE BEFORE IMPLANTATION OF EXPANDABLE SPINAL DEVICES. A COMPARISON OF RESULTS AND COMPLICATIONS IN EARLY-ONSET SPINAL DEFORMITY. J. SPINAL DISORDER TECH, VOLUME 24, NUMBER 2, 99-104. 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 FILLED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE "HALO-GRAVITY TRACTION VERSUS SURGICAL RELEASE BEFORE IMPLANTATION OF EXPANDABLE SPINAL DEVICES". AN OBSERVATIONAL STUDY OF 124 PATIENTS WITH SEVERE EARLY-ONSET SPINAL DEFORMITY WERE TREATED WITH THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) OR GROWING RODS. OF THE 124 PATIENTS, 96 PATIENTS HAD ALL THE RADIOGRAPHIC DATA REQUIRED FOR THE STUDY. BEFORE IMPLANTATION OF THE DEVICE, 12 UNDERWENT HALO-GRAVITY TRACTION (HGT) AND 13 HAD A SURGICAL RELEASE (SR). THIS STUDY IS BASED ON X-RAYS OBTAINED BEFORE AND AFTER SURGERY AND AT THE LAST FOLLOW-UP AND ON MEDICAL RECORDS. THE THORACIC SCOLIOSIS AND KYPHOSIS, AND THE THORACIC HEIGHT AND SPINAL LENGTH WAS MEASURED ON THE X-RAYS. POST-OPERATIVE COMPLICATIONS WERE ALSO COLLECTED. AT 7 MONTH FOLLOW-UP ONE MALE PATIENT FROM THE SURGICAL RELEASE GROUP IMPLANTED WITH VEPTR HAD UPPER RIB ATTACHMENT LOOSENING. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT FOR AN UNKNOWN VEPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247603 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1