BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, PEDICLE SPINAL FIXATION

    MDR report key: 8571512 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63372
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR A USS SYNTHES DEVICE/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. (B)(4). 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: GILBERTO AGUSTÍN GONZÁLEZ-TREVIZO, RAFAEL MOTA-BOLFETA, HORTENSIA ROMERO-LEGUIZAMO, AND VICTORIO DE LA FUENTE NARVÁEZ (2003), EFFICACY OF THE DOUBLE APPROACH IN SCHEUERMANN'S DISEASE. DESCRIPTION OF CLINICAL CASES, ACTA ORTOPEDICA MEXICANA VOL. 17(5), PAGES 221-224 (MEXICO). THE AIM OF THE RETROSPECTIVE STUDY IS TO CHECK THE EFFICACY OF THE DOUBLE APPROACH IN DIAGNOSIS OF SCHEUERMANN¿S DISEASE THAT WAS CONSIDERED WHEN THERE WAS: A) MORE THAN 5 DEGREES OF WEDGING OF AT LEAST THREE ADJACENT VERTEBRAE AT THE APEX OF THE KYPHOSIS, B) IRREGULARITIES OF THE VERTEBRAL PLATES, C) THORACIC KYPHOSIS ABOVE 45 DEGREES AND E) PRESENCE OF SCHMORL NODULES. BETWEEN 1994 TO 2001, A TOTAL OF 60 PATIENTS DIAGNOSED WITH SCHEUERMANN¿S DISEASE, OF WHOM 40 HAD SURGERY, ALTHOUGH ONLY 15 PATIENTS ALL MALES WITH A MEAN AGE OF 17 YEARS (RANGE, 9-45 YEARS) HAD CLINICAL AND RADIOLOGICAL RECORDS AND A (B)(6) YEAR-OLD PATIENT WHO WAS OUTSIDE OF THE AVERAGE WAS INCLUDED AT THIS AGE DUE TO CARDIOPULMONARY COMPROMISE WERE INCLUDED IN THE STUDY. THE USS SYSTEM WAS USED FOR 10 PATIENTS WITH SUBLAMINAR HOOKS, WHICH ARE ONLY FIXED TO THE LAMINAE AND DO NOT PENETRATE THE MEDULLARY CANAL FOR THE PATIENTS WITH SCHEUERMANN¿S DISEASE. THE FINAL FOLLOW-UP IS 2 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 6 PATIENTS PRESENTED SYSTEM DETACHMENT. 2 PATIENTS HAD TO REMOVE THE INSTRUMENTS WITHOUT AFFECTING VERTEBRAL FUSION BECAUSE IT WAS PERFORMED 2 YEARS AFTER THE SURGERY. THIS REPORT CAPTURES 6 PATIENTS WHO PRESENTED SYSTEM DETACHMENT. THIS REPORT IS FOR A USS SYNTHES DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362217 ORTHOSIS, PEDICLE SPINAL FIXATION MNI OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention