BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8646248 · Received May 28, 2019

    Report

    Report Number
    8030965-2019-64583
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    June 14, 2013
    Report Date
    April 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINAL SYSTEM (USS)/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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: WEINER, X. ET AL (2013), IMPACT OF SURGICAL STRATEGY ON QUALITY OF LIFE AND RADIOLOGICAL OUTCOME IN TRAUMATIC FRACTURES OF THE THORACOLUMBAR SPINE, ZEITSCHRIFT FUR ORTHOPADIE UND UNFALLCHIRURGIE (2013) VOLUME 151(3) PAGES 264-271 (GERMANY), DOI: 10.1055/S-0032-132865. THE AIM OF THE PRESENT STUDY WAS TO INVESTIGATE THE INFLUENCE OF THE OPERATIVE STRATEGY ON THE OUTCOME OF TRAUMATIC VERTEBRAL BODY FRACTURES OF THE THORACOLUMBAR JUNCTION. BETWEEN FEBRUARY 2001 TO DECEMBER 2007,413 PATIENTS WITH VERTEBRAL BODY FRACTURES WERE TREATED SURGICALLY. A TOTAL OF 133 PATIENTS AGED BETWEEN 16 AND 65 YEARS WITH A TRAUMATIC VERTEBRAL FRACTURE OF THE THORACOLUMBAR JUNCTION WERE IDENTIFIED AS ELIGIBLE FOR FOLLOW-UP. OF THE 133 PATIENTS ENROLLED, 46 DID NOT SHOW UP FOR THE FOLLOW-UP. IN TOTAL,87 PATIENTS (52 MALE 35 FEMALE) WITH AN AVERAGED AGE OF 45 YEARS WERE INCLUDED IN THE STUDY. INITIALLY,ALL THE PATIENTS HAD RECEIVED OPEN DORSAL INSTRUMENTATION WITHOUT DORSAL SPONDYLODESIS (USS®, SYNTHES, FREIBURG).THE PATIENTS WERE DIVIDED INTO 4 GROUPS. 22 PATIENTS IN THE FIXATOR GROUP, NO FURTHER INTERVENTION WERE DONE. 15 PATIENTS ARE IN THE SPAN GROUP, WITH BONE GRAFT FROM THE ILIAC CREST WITHOUT ADDITIONAL VENTRAL PLATE. 22 PATIENTS ARE IN THE MACS GROUP ,WITH BONE GRAFT FROM THE ILIAC CREST WITHOUT ADDITIONAL VENTRAL PLATE (MACS®, B. BRAUN/AESCULAP, TUTTLINGEN) AND 28 PATIENTS ARE IN THE CAGE GROUP (OBELISK®, ULRICH, ULM). ALL GROUPS WERE FURTHER DIVIDED INTO PATIENTS WHO HAD ALREADY UNDERGONE AN IMPLANT REMOVAL AT THE TIME OF THE FOLLOW-UP EXAMINATION AND THOSE IN WHOM THE FIXATOR WAS STILL IN SITE. THE AVERAGE FOLLOW-UP PERIOD WAS 40.8 MONTHS (18-74 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT IN THE MACS GROUP WITHOUT IMPLANT REMOVAL HAD UNHEALED GRAFT. WORST HEALING RATE IN THE SPAN GROUP WHERE THE INTERNAL FIXATOR WAS STILL INTACT. 5 PATIENTS HAD ALREADY DIED AT THE TIME OF THE FOLLOW-UP EXAMINATION. THIS REPORT CAPTURES THE ADVERSE EVENTS OF UNHEALED GRAFT, WORST HEALING RATE. THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINAL SYSTEM (USS). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439082 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention