BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8726659 · Received June 24, 2019

    Report

    Report Number
    8030965-2019-65578
    Event Type
    Injury
    Date Received
    June 24, 2019
    Report Date
    May 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WIMMER, C. AND PFANDLSTEINER, T (2010), 6 YEARS FOLLOW UP IN THE TREATMENT OF SEVERE SPINAL DEFORMITIES, EUROPEAN SPINE JOURNAL, VOL. 19, PAGE 1995 (GERMANY). SINCE 2002 THE TREATMENT WITH VEPTR IS ESTABLISHED IN EUROPE. FROM 2005 TO 2010, 48 PATIENTS (19 MALES AND 29 FEMALES) WITH THE AVERAGE AGE OF 7.5 WERE TREATED WITH AN UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). IN 22 CASES A RIB TO LUMBAR SPINE HYBRID WAS USED. IN 20 CASES A COMBINATION FROM RIB TO RIB WAS USED AND IN 6 CASES A RIB TO PELVIS CONSTRUCT WAS USED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT SHOWED A PROLONGED WOUND HEALING. 1 PATIENT HAD PNEUMONIA WHICH RESOLVED WITH ADEQUATE THERAPY. THE RIB DEVICES PULL OUT AFTER THE LENGTHENING PROCEDURE IN 5 CASES. 39 OUT OF 48 PATIENTS HAD 1 TO 9 LENGTHENING PROCEDURES. IN 15 OF THE PATIENTS THE SECOND CURVE MUST BE INSTRUMENTED. 3 CASES HAD SKIN BREAKAGE AND THE INSTRUMENTATION WAS REMOVED. 4 CASES, A FINAL FUSION WAS PERFORMED. THIS IS FOR AN UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523280 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention