BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11791565 · Received May 7, 2021

    Report

    Report Number
    1526439-2021-00921
    Event Type
    Injury
    Date Received
    May 7, 2021
    Report Date
    April 13, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. 510K: THIS REPORT IS FOR AN UNKNOWN CAGE OR SPACER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN 2006 TO 2016. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHIRAHATA T., ET AL (2020)ASSOCIATION BETWEEN SURGICAL LEVEL AND EARLY POSTOPERATIVE THIGH SYMPTOMS AMONG PATIENTS UNDERGOING STANDALONE LATERAL LUMBAR INTERBODY FUSION, WORLD NEUROSURGERY VOLUME 134, PAGES E885-E891 (JAPAN) HTTPS://DOI.ORG/10.1016/J.WNEU.2019.11.025. THIS STUDY AIMS TO INVESTIGATE THE DIFFERENCES IN THE INCIDENCE OF POSTOPERATIVE THIGH SYMPTOMS (PAIN AND PARESTHESIA) STRATIFIED BY PROCEDURE LEVEL AMONG PATIENTS WHO HAD UNDERGONE STANDALONE LLIF. FROM 2006 TO 2016, 1290 CONSECUTIVE LLIF CASES PERFORMED WERE REVIEWED. A TOTAL OF 285 PATIENTS WITH MEAN AGE OF 62.8 -13.1 YEARS WHO HAD UNDERGONE STANDALONE LLIF USING EITHER THE XLIF SYSTEM (XLIF-NUVASIVE, INC., (B)(6), USA) OR THE COUGAR SYSTEM (COUGAR-DEPUY SPINE INC., (B)(6), USA), WITHOUT SUPPLEMENTAL POSTERIOR FIXATION, WERE INCLUDED. THE PATIENTS WERE FOLLOWED UP 6-WEEK POSTOPERATIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED: 121 HAD REPORTED POSTOPERATIVE THIGH SYMPTOMS. OF THESE 121 PATIENTS, 81 HAD REPORTED ANTERIOR THIGH PAIN AND 62 HAD REPORTED ANTERIOR THIGH PARESTHESIA. PARESTHESIA WAS SIGNIFICANTLY ASSOCIATED WITH SURGERY AT THE L2-L3 LEVEL :PARESTHESIA (N=17) AND PAIN (N=28). THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CAGE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690387 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD DEPUY SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention