BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8518805 · Received April 16, 2019

    Report

    Report Number
    8030965-2019-62830
    Event Type
    Injury
    Date Received
    April 16, 2019
    Report Date
    March 22, 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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.

    Description of Event or Problem · 0

    THIS REPORT CAPTURES THE REPORTED EVENT OF SURGICAL SITE INFECTION REQUIRING SURGICAL REVISION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN- CONSTRUCTS: USS/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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FLORIAN BAUMANN, M.D. ET AL (2015), POSTEROLATERAL FUSION IN ACUTE TRAUMATIC THORACOLUMBAR FRACTURES: A COMPARISON OF DEMINERALIZED BONE MATRIX AND AUTOLOGOUS BONE GRAFT, ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSL., VOL.82, 2015, P. 119¿125 (GERMANY). PURPOSE OF THIS STUDY WAS TO EVALUATE DEMINERALIZED BONE MATRIX (DBM) IN PLF AS AN ALTERNATIVE TO THE GOLD STANDARD OF ABG IN ACUTE TRAUMATIC VERTEBRAL BODY FRACTURES OF THE THORACOLUMBAR SPINE. BETWEEN 2005 AND 2011, WE RETROSPECTIVELY IDENTIFIED 101 PATIENTS WITH ACUTE TRAUMATIC VERTEBRAL BODY FRACTURES OF THE THORACIC AND LUMBAR SPINE WHO WERE TREATED WITH INSTRUMENTED PLF IN OUR LEVEL ONE TRAUMA CENTER. UNTIL AUGUST 2008, AUTOLOGOUS BONE GRAFT HARVESTED FROM THE POSTERIOR ILIAC CREST WAS USED IN PLF (CONTROL GROUP N = 46). STARTING SEPTEMBER 2008, DBM WAS USED AS FUSION EXPANDER IN PLF (STUDY GROUP N = 16). IN 31 PATIENTS, DBM WAS USED FOR PLF. 15 PATIENTS WERE EXCLUDED DUE TO PRIMARY PARAPLEGIA (5 PATIENTS), OSTEODEPRIVING DISEASE (7 PATIENTS), AND LOSS TO FOLLOW-UP (2 PATIENTS). ONE PATIENT HAD RECEIVED DBM IN ADDITION TO AN ABG AND WAS THEREFORE EXCLUDED. FINALLY, 16 PATIENTS WERE INCLUDED IN THE DBM GROUP. IN 71 PATIENTS, ABG WAS USED FOR PLF. IN THIS GROUP, 25 PATIENTS WERE EXCLUDED DUE TO PRIMARY PARAPLEGIA (3 PATIENTS), OSTEODEPRIVING DISEASE (5 PATIENTS), AND LOSS TO FOLLOW-UP (16 PATIENTS). THE PATIENT MENTIONED ABOVE WHO HAD RECEIVED ABG AND DBM AND WAS AGAIN EXCLUDED. FINALLY, 46 PATIENTS WERE INCLUDED IN THE ABG GROUP, REPRESENTING THE CONTROL GROUP. IN TOTAL, DATA OF 62 PATIENTS (16 DBM; 46 ABG) WERE AVAILABLE FOR ANALYSIS. THE MEAN AGE OF THE INCLUDED PATIENTS AT THE TIME OF SURGERY WAS 43.5 ± 3.2, AND 45.2 ± 2.5 YEARS IN DBM AND ABG, RESPECTIVELY. THE STUDY COHORT COMPRISED 11 MEN (68.8%) AND 5 WOMEN (31.2%) IN DBM AND 32 MEN (70.0%) AND 14 WOMEN (30.0%) IN ABG. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 CASES OF SURGICAL SITE INFECTION REQUIRING SURGICAL REVISION DUE TO SUPERFICIAL SITE INFECTION IN THE ABG GROUP. 1 SURGICAL SITE INFECTION DUE TO DELAYED DEEP INFECTION ON THE DBM GROUP. A (B)(6) YEAR-OLD FEMALE DEVELOPED A NON-UNION DUE TO LOW-GRADE INFECTION AROUND 3RD LUMBAR VERTEBRAL BODY SEVEN MONTHS AFTER THE DORSOVENTRAL STABILIZATION. THIS REPORT IS FOR UNIVERSAL SPINE SYSTEM (USS). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311478 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention