BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMON NAME PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3776439 · Received April 28, 2014

    Report

    Report Number
    2520274-2014-11062
    Event Type
    Injury
    Date Received
    April 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. COMPLICATIONS IN PEDIATRIC SPINE SURGERY USING THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB. LIPPINCOTT WILLIAMS & WILKINS SPINE VOLUME 38, NUMBER 25 (2011), PP E1589¿E1599. 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. COMPLICATIONS IN PEDIATRIC SPINE SURGERY USING THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB; GRÉGORY LUCAS , MD, GÉRARD BOLLINI , MD, JEAN-LUC JOUVE , MD , JÉROME SALES DE GAUZY , MD , FRANCK ACCADBLED , MD , PIERRE LASCOMBES , MD , PIERRE JOURNEAU , MD , CLAUDE KARGER , MD , JEAN FRANÇOIS MALLET , MD , PETRE NEAGOE , MD , JÉROME COTTALORDA , MD , BENOIT DE BILLY , MD , JEAN LANGLAIS , MD , BERNARD HERBAUX , MD , DAMIEN FRON , MD , AND PHILIPPE VIOLAS , MD. LIPPINCOTT WILLIAMS & WILKINS SPINE VOLUME 38, NUMBER 25 (2011), PP E1589¿E1599. THIS IS MULTICENTER RETROSPECTIVE STUDY TO DESCRIBE THE COMPLICATION RATE OF THE FRENCH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) SERIES INVOLVING PATIENTS TREATED BETWEEN AUGUST 2005 AND JANUARY 2012. OF THE 58 CASE FI LES, 54 WERE AVAILABLE FOR ANALYSIS. THE SERIES INVOLVED 33 GIRLS AND 21 BOYS WITH A MEAN AGE OF 7 YEARS (RANGE, 20 MONTHS¿14 YEARS AND 2 MONTHS) AT PRIMARY VEPTR SURGERY. DURING THE FOLLOW-UP PERIOD, SEVERAL COMPLICATIONS OCCURRED. MEAN FOLLOW-UP WAS 22.5 MONTHS (RANGE, 6¿64 MO). IN TOTAL, 184 PROCEDURES WERE PERFORMED, INCLUDING 56 VEPTR IMPLANTATIONS, 98 EXPANSIONS, AND 30 NONSCHEDULED PROCEDURES FOR DIFFERENT TYPES OF COMPLICATIONS: MECHANICAL COMPLICATIONS (I.E. FRACTURE, DEVICE MIGRATION), DEVICE-RELATED AND INFECTIOUS COMPLICATIONS, NEUROLOGICAL DISORDERS, SPINE STATICS DISTURBANCES. ALTOGETHER, THERE WERE 74 COMPLICATIONS IN 54 PATIENTS: A COMPLICATION RATE OF 137% PER PATIENT AND 40% PER SURGERY. COMPARISON OF THE COMPLICATIONS IN THIS SERIES WITH THOSE REPORTED IN THE LITERATURE LED THE AUTHORS TO SUGGEST SOLUTIONS THAT SHOULD HELP DECREASE THEIR INCIDENCE. THIS REPORT IS FOR UNKNOWN VEPTR CONSTRUCT. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4), FOR OPERATIVE SITE INFECTION (6 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254302 COMMON NAME PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention