BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8499905 · Received April 10, 2019

    Report

    Report Number
    8030965-2019-62664
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    March 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN USS CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN 1999 AND 2007. 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: AEBLI N, KAISER T, MOULIN P, KRENBS J (2014). SHORT-SEGMENT POSTERIOR INSTRUMENTATION COMBINED WITH ANTERIOR SPONDYLODESIS USING AN AUTOLOGOUS RIB GRAFT IN THORACOLUMBAR BURST FRACTURES. ACTA ORTHOPAEDICA. VOLUME 85. PAGE 84-90. (SWITZERLAND). THIS RETROSPECTIVE STUDY INVESTIGATED THE CLINICAL AND RADIOGRAPHIC OUTCOME AFTER POSTERIOR BISEGMENTAL INSTRUMENTATION AND MONOSEGMENTAL SPONDYLODESIS COMBINED WITH ANTERIOR MONOSEGMENTAL SPONDYLODESIS USING AN AUTOLOGOUS RIB GRAFT FOR TREATMENT OF THORACOLUMBAR BURST FRACTURES. BETWEEN 1999 AND 2007, 37 PATIENTS WERE TREATED WITH POSTERIOR BISEGMENTAL INSTRUMENTATION AND MONOSEGMENTAL SPONDYLODESIS COMBINED WITH ANTERIOR MONOSEGMENTAL SPONDYLODESIS USING AN AUTOLOGOUS RIB GRAFT FOR THORACOLUMBAR BURST FRACTURES (T11¿L2). 5 PATIENTS WERE LOST TO FOLLOW-UP. 32 PATIENTS WERE ANALYZED AND INCLUDED IN STUDY. THEY CONSISTED OF 26 MALES AND 6 FEMALES WITH A MEDIAN AGE OF 31 (RANGE, 16-67 YEARS) AT THE TIME OF INJURY. A 2-STAGE PROCEDURE WAS PERFORMED. THE FIRST PROCEDURE INVOLVED POSTERIOR FRACTURE REDUCTION, RESTORATION OF THE SAGITTAL PLANE ALIGNMENT, AND STABILIZATION USING AN UNKNOWN SYNTHES UNIVERSAL SPINE SYSTEM. POSTERIOR INSTRUMENTATION INVOLVED 2 MOTION SEGMENTS. AUTOLOGOUS VERTEBRAL BONE¿ AND IF NECESSARY ALLOLOGOUS (COMPETITOR¿S DEVICE) OR XENOLOGOUS BONE (COMPETITOR¿S DEVICE) WAS USED FOR MONOSEGMENTAL POSTERIOR SPONDYLODESIS. AFTER APPROXIMATELY 10 DAYS, THE SECOND PROCEDURE WAS PERFORMED WITH ANTERIOR SPONDYLODESIS USING A RIB GRAFT. IN SOME PATIENTS, WHEN RESPIRATORY AND CARDIOVASCULAR CONDITION ALLOWED, POSTERIOR AND ANTERIOR PROCEDURES WERE PERFORMED AS 1 STAGE. THE MONOSEGMENTAL COBB ANGLE WAS MEASURED PREOPERATIVELY, POSTOPERATIVELY, THEN 6 AND 12 MONTHS POSTOPERATIVELY, AND ALSO AFTER IMPLANT REMOVAL. POSTOPERATIVE PAIN WAS ASSESSED ON A NUMERIC RATING SCALE (NRS) FROM 0 TO 10 (MILD PAIN: 1¿4; MODERATE PAIN: 5¿7; SEVERE PAIN: 8¿10). IN 22 PATIENTS, POSTERIOR INSTRUMENTATION WAS REMOVED AFTER A MEDIAN TIME OF 19 (13¿32) MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD MALE PATIENT HAD TRANSIENT INTERCOSTAL NEURALGIA. THE IMPLANT WAS REMOVED AT 19 MONTHS AFTER SURGERY. A (B)(6) YEAR-OLD MALE PATIENT HAD CHRONIC INTERCOSTAL NEURALGIA. THE IMPLANT WAS REMOVED AT 25 MONTHS AFTER SURGERY. A (B)(6) YEAR-OLD MALE PATIENT HAD POSTOPERATIVE MILD BACK PAIN WITH A NUMERIC RATING SCALE OF 1-4. THE IMPLANT WAS NOT REMOVED. A (B)(6) YEAR-OLD FEMALE PATIENT HAD POSTOPERATIVE MILD BACK PAIN WITH A NUMERIC RATING SCALE OF 1-4. THE IMPLANT WAS NOT REMOVED. THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINE SYSTEM (USS) CONSTRUCT. THIS IS REPORT 3 OF 4 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293105 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention