BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

    MDR report key: 8660360 · Received May 31, 2019

    Report

    Report Number
    8030965-2019-64760
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    April 16, 2018
    Report Date
    May 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNTHES T-PAL/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: MARENGO, N. ET AL (2018), CORTICAL BONE TRAJECTORY SCREWS FOR CIRCUMFERENTIAL ARTHRODESIS IN LUMBAR DEGENERATIVE SPINE: CLINICAL AND RADIOLOGICAL OUTCOMES OF 101 CASES, EUROPEAN SPINE JOURNAL, VOL. 27 (2), PAGES S213-221 (ITALY). THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO REPORT ON THE OPERATIVE OUTCOMES, CLINICAL RESULTS AND COMPLICATIONS IN A HOMOGENEOUS SERIES OF PATIENTS WHO UNDERWENT POSTERIOR LUMBAR FIXATION AND INTERBODY FUSION PERFORMED AT A SINGLE INSTITUTION. BETWEEN APRIL 29, 2014 TO AUGUST 18, 2017, A TOTAL OF 101 ADULT PATIENTS (58 MALES AND 43 FEMALES) WITH A WITH A MEAN AGE WAS 47.6 YEARS, UNDERWENT LUMBAR FUSION. SURGERY WAS PERFORMED USING T-PAL (DEPUY SYNTHES, OBERDORF, CH). THE MEAN FOLLOW-UP WAS 18.23 MONTHS (RANGE 3¿42 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 WOUND INFECTION MANAGED SUCCESSFULLY WITH ORAL ANTIBIOTICS; 1 PSEUDOMENINGOCELE AFTER INCIDENTAL DUROTOMY WAS MANAGED SUCCESSFULLY WITH BED REST FOR 7 DAYS. THE MEAN ODI AT 1-MONTH FOLLOW-UP WAS 23.27, AND 17.56 AT THE LAST FOLLOW-UP. MEAN VAS AT 1-MONTH FOLLOW-UP WAS 3.36 AND 2.44 AT THE LAST FOLLOW-UP. MEAN LORDOSIS INCREMENT AT THE TREATED LEVEL WAS 4.2°. THE MEAN OPERATIVE BLOOD LOSS WAS 383 ML. SIX PERCENT OF CASES DID NOT OBTAIN FUSION AT 12-MONTH FOLLOW-UP. THIS REPORT CAPTURES THE REPORTED EVENTS SUCH AS WOUND INFECTION, PSEUDOMENINGOCELE, MEAN ODI, MEAN VAS, MEAN LORDOSIS, MEAN BLOOD LOSS, AND THOSE DID NOT OBTAIN FUSION. THIS REPORT IS FOR AN UNKNOWN SYNTHES T-PAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453116 INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention