BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

    MDR report key: 7338533 · Received March 14, 2018

    Report

    Report Number
    8030965-2018-52058
    Event Type
    Injury
    Date Received
    March 14, 2018
    Report Date
    April 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE WAS INADVERTENTLY NOT ATTACHED DURING INITIAL REPORTING (MWR-(B)(4)). ARTICLE IS ATTACHED NOW. 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THE PRODUCT WAS NOT RETURNED. 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. LITERATURE ARTICLE WAS INADVERTENTLY NOT ATTACHED DURING INITIAL REPORTING (MWR-26022018-0000063262) AND FOLLOW-UP REPORT (MWR-04042018-0000086286). ARTICLE IS ATTACHED NOW. 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. - ATTACHMENT: [(B)(4) WANG ET AL., 2017 (1).PDF]

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR THREE (3) CAGES OR PLATES - UNKNOWN LOT; UNKNOWN PART. UDI NUMBER IS UNKNOWN. IMPLANT DATE: UNKNOWN. THERE IS NO INDICATION THAT THE DEVICE WAS REMOVED. COMPLAINANT PART HAS NOT BEEN RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: YU WANG ET. AL (2017) ANTERIOR DISCECTOMY COULD STILL BE AN ALTERNATIVE TO CORPECTOMY IN HIGHLY MIGRATED CERVICAL DISC HERNIATION, BRITISH JOURNAL OF NEUROSURGERY, VOLUME 31:6, PAGES 709-713, (B)(6). THE AIM OF THIS ARTICLE IS TO ANALYZE THE FEASIBILITY OF ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR PATIENTS WITH HIGHLY MIGRATED CERVICAL DISC (HMCD) HERNIATION. FOR CASES WHERE ACDF IS NOT FEASIBLE, ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF) WAS PERFORMED. A TOTAL OF 32 PATIENTS (18 MALE AND 14 FEMALE, RANGED FROM 42-80 YEARS WITH A MEDIAN AGE OF 61.7 YEARS) WITH HMCD TREATED WITH ACDF OR ACCF WERE RETROSPECTIVELY REVIEWED BETWEEN JANUARY 2009 AND NOVEMBER 2015. 27 WERE TREATED WITH ACDF AND 5 WERE TREATED WITH ACCF. THREE (3) PATIENTS HAD TRANSIENT OR LONG-TERM DYSPHAGIA POST-OPERATIVELY (ACCF GROUP). NO MALFUNCTION WAS REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CAGE OR PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182458 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention