BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3761835 · Received April 21, 2014

    Report

    Report Number
    2520274-2014-10915
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. PAJULO, O., KYLLANEN, K., PELTONEN, J., HELENIUS, I., (2012), COMPLICATIONS IN PATIENTS WITH VEPTR INSTRUMENTATION ARE STRONGLY ASSOCIATED WITH BASIC DIAGNOSIS, JOURNAL OF CHILDREN'S ORTHOPAEDICS, 6 (SUPPL 1):S35¿S55. DOI 10.1007/S11832-012-0390-6. THIS REPORT IS FOR AN UNKNOWN VEPTR. 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: PAJULO, O., KYLLANEN, K., PELTONEN, J., HELENIUS, I., (2012), COMPLICATIONS IN PATIENTS WITH VEPTR INSTRUMENTATION ARE STRONGLY ASSOCIATED WITH BASIC DIAGNOSIS, JOURNAL OF CHILDREN'S ORTHOPAEDICS, 6 (SUPPL 1):S35¿S55. DOI 10.1007/S11832-012-0390-6. THE AIM OF THIS STUDY WAS TO ANALYZE THE RESULTS AND THE COMPLICATIONS, RELATED TO THE DIAGNOSIS AND THE AGE OF THE PATIENT. THE MATERIAL CONSISTS OF 18 PATIENTS, ELEVEN BOYS AND SEVEN GIRLS AND THEY RECEIVED A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). THE AGE AT THE TIME OF OPERATION RANGE 1.0¿16.7 YEARS AND THE FOLLOW-UP TIME RANGE 0.6¿5.7 YEARS. THE OPERATION INDICATIONS WERE CONGENITAL SCOLIOSIS IN EIGHT PATIENTS, NEUROMUSCULAR SCOLIOSIS IN FIVE, INFANTILE SCOLIOSIS IN THREE AND ONE HYPERLORDOSIS AND ONE HYPERKYPHOSIS PATIENT. THERE WERE 22 COMPLICATIONS IN NINE PATIENTS, WHEREAS THE OTHER NINE PATIENTS DID NOT HAVE ANY. THE MOST COMMON COMPLICATION WAS LOOSENING OF THE VEPTR FOUNDATION IN 18 CASES. ONLY IN TWO CASES WAS AN EMERGENCY OPERATION NEEDED AND THE OTHERS WERE CORRECTED AT THE NEXT SCHEDULED OPERATION. IN FOUR CASES THERE WERE SKIN PROBLEMS AND THE VEPTR INSTRUMENTATION HAD TO BE REMOVED IN THREE CASES, PERMANENTLY IN TWO. THE AUTHOR CONCLUDED THAT VEPTR INSTRUMENTATION SEEMS TO WORK BEST IN YOUNG PATIENTS WITH CONGENITAL SCOLIOSIS. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. LOOSENING WITHOUT REVISION. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. 1 OF 3 MEDWATCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241255 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention