BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8510634 · Received April 12, 2019

    Report

    Report Number
    8030965-2019-62777
    Event Type
    Injury
    Date Received
    April 12, 2019
    Report Date
    March 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINE SYSTEM/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: PAPAKOSTIDIS, C ET AL (2005), UNIQUE COMBINATION OF LUMBOSACRAL JUNCTION INJURY WITH OPEN PELVIC RING DISRUPTION AND ACETABULUM FRACTURE SPINE, VOL. 30 PAGES 477-480 (UNITED KINGDOM). THIS CASE PRESENTATION IS TO DESCRIBE THE MECHANISM, DIAGNOSTIC APPROACH, AND RATIONALE FOR TREATMENT OF THIS VERY RARE AND COMPLEX INJURY PATTERN AND FINALLY TO PRESENT THE RESULTS OF THE TREATMENT. A (B)(6) YEAR-OLD MALE UNDERWENT POSTERIOR LUMBOPELVIC SEGMENTAL FIXATION USING THE UNKNOWN AZIENDA OSPEDALIERA UNIVERSAL SPINE SYSTEM. TWO YEARS AFTER INJURY, THE PATIENT WAS INDEPENDENTLY AMBULATORY AND PAIN FREE FROM THE LOWER SPINE AND PELVIS, ALTHOUGH WITH A PERMANENT FOOT DROP OF HIS RIGHT LEG, TREATED WITH AN ANKLE-FOOT ORTHOSIS. THE PATIENT HAD HETEROTOPIC OSSIFICATION DEVELOP, BUT THERE WAS NO RESTRICTION IN THE RANGE OF MOTION OF THE RIGHT HIP. THIS REPORT IS FOR A (B)(6) YEARS OLD MALE PATIENT WHO HAD PERMANENT FOOT DROP OF HIS RIGHT LEG, TREATED WITH AN ANKLE-FOOT ORTHOSIS. THIS REPORT IS FOR AN UNKNOWN UNIVERSAL SPINE SYSTEM. THIS REPORT IS 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302559 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention