BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06471

    MDR report key: 3360212 · Received September 20, 2013

    Report

    Report Number
    2520274-2013-06471
    Event Type
    Injury
    Date Received
    September 20, 2013
    Report Date
    August 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS. STUDIES IN HEALTH TECHNOLOGY AND INFORMATICS(2012)176 (PP 334-337). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER PROVIDED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ENTITLED: COMPLICATIONS INCIDENCE IN THE TREATMENT OF EARLY ONSET SCOLIOSIS WITH GROWING SPINAL IMPLANTS. GREGGI T., LOLLI F., DI SILVESTRE M., MARTIKOS K., VOMMARO F., MAREDI E., GIACOMINI S., BAIONI A., CIONI A. STUDIES IN HEALTH TECHNOLOGY AND INFORMATICS. 176 (PP 334-337)2012. A RETROSPECTIVE REVIEW WAS CONDUCTED TO IDENTIFY ALL PEDIATRIC PATIENTS AFFECTED BY EOS (EARLY ONSET SCOLIOSIS) SURGICALLY TREATED WITH GROWING ROD OR VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) BETWEEN 2006 AND 2011. NINETEEN CONSECUTIVE PATIENTS (8 MALES, 11 FEMALES; MEAN AGE 6.8 YEARS) WERE INCLUDED. THE SCOLIOSIS WAS: IDIOPATHIC IN 7 CASES, CONGENITAL IN 5, ASSOCIATED WITH CONGENITAL HEART DISEASE IN 2, WITH SYRINGOMYELIA AND ARNOLD CHIARI SYNDROME IN 1, WITH NEUROFIBROMATOSIS TYPE 1 (NF1) IN 1, WITH PRADER WILLI SYNDROME IN 1, WITH TRISOMY 8 IN 1, WITH ARTHROGRYPOSIS IN 1. INSTRUMENTATION USED WAS: GROWING ROD IN 9 PATIENTS (DUAL ROD CONSTRUCT IN 8 CASES, SINGLE ROD IN 1), VEPTR IN 10 (ALWAYS RIB TO SPINE CONSTRUCT). AT A MEAN FOLLOW-UP OF 28 MONTHS (RANGE, 12 TO 55) 12 MECHANICAL COMPLICATIONS OCCURRED IN 8 OF 19 PATIENTS TREATED (42.1 PERCENT). AMONG CASES TREATED WITH GROWING ROD (9) 6 COMPLICATIONS OCCURRED IN 4 PATIENTS (44.4 PERCENT): REVISION WAS PERFORMED IN 4 CASES DUE TO PROXIMAL ANCHORS MIGRATION, IN 2 CASES DUE TO A ROD BREAKAGE. AMONG CASES TREATED WITH VEPTR (10) 6 COMPLICATIONS OCCURRED IN 4 PATIENTS (4 PERCENT): REVISION WAS PERFORMED IN 4 CASES DUE TO RIB FRACTURE WITH ANCHORS MIGRATION, IN 1 CASE DUE TO VERTEBRAL ANCHOR MIGRATION AND IN 1 CASE DUE TO PROXIMAL AND DISTAL ANCHOR MIGRATION. THIS REPORT IS FOR AN UNKNOWN VEPTR PART. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474805 KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention