BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3776215 · Received April 28, 2014

    Report

    Report Number
    2520274-2014-11045
    Event Type
    Malfunction
    Date Received
    April 28, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ARTICLE REFERS TO THE PATIENT AS PATIENT NO. 10. DATE OF EVENT- NO DATE PROVIDED. SPINE, VOLUME 38, NUMBER 24. THIS REPORT IS FOR 1 UNKNOWN VEPTR CONSTRUCT. KARATAS, A. ET AL. (2013). GROWTH-SPARING SPINAL INSTRUMENTATION IN SKELETAL DYSPLASIA. SPINE, VOLUME 38, NUMBER 24, PP E1517-E1526. 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: ¿GROWTH-SPARING SPINAL INSTRUMENTATION IN SKELETAL DYSPLASIA¿. THE PURPOSE OF THE STUDY IS TO REPORT THE OUTCOMES OF DISTRACTION-BASED, GROWTH-SPARING SPINAL INSTRUMENTATION IN PATIENTS WITH SKELETAL DYSPLASIA. BETWEEN 2004 AND 2010, 12 CHILDREN WITH A DIAGNOSIS OF VARIOUS TYPES OF SKELETAL DYSPLASIA UNDERWENT GROWTH-SPARING SPINAL INSTRUMENTATION FOR SEVERE SPINAL DEFORMITIES. THREE OF THE PATIENTS WERE TREATED WITH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). OF THE 3 PATIENTS, ONE HAD A COMPLICATION OF PROXIMAL MIGRATION OF RIB CRADLE, WHICH REQUIRED REVISION, AND THE OTHER 2 PATIENTS HAD ANCHOR DISLODGEMENTS, WHICH WERE ADDRESSED DURING PLANNED DISTRACTION SURGICAL PROCEDURES. THIS IS REPORT 3 OF 3 FOR (B)(4) AND IS FOR ONE UNKNOWN VEPTR CONSTRUCT. ¿PATIENT (B)(6) ¿, (B)(6) AT THE TIME OF SURGERY, HAD A COMPLICATION OF SCREW DISLODGEMENT WHICH WAS ADDRESSED DURING PLANNED DISTRACTION SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254874 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 86 MO Required Intervention