BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 9554740 · Received January 6, 2020

    Report

    Report Number
    1526439-2020-00174
    Event Type
    Injury
    Date Received
    January 6, 2020
    Report Date
    December 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4). 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: LUMAWIG JMT, YAMAZAKI A, WATANABE K (2009), DOSE-DEPENDENT INHIBITION OF DICLOFENAC SODIUM ON POSTERIOR LUMBAR INTERBODY FUSION RATES, THE SPINE JOURNAL, VOLUME 9, PAGE 343-349, (JAPAN). THE PURPOSE OF THIS STUDY IS TO DETERMINE IF DICLOFENAC SODIUM IS A RISK FACTOR FOR DELAYED UNION AND NONUNION IN ADULT PATIENTS WHO UNDERWENT ONE- TO TWO-LEVEL INSTRUMENTED POSTERIOR LUMBAR INTERBODY FUSION (PLIF) USING ONLY LOCAL AUTOGENOUS BONE GRAFT. BETWEEN JANUARY 1999 TO DECEMBER 2004, 279 PATIENTS WHO UNDERWENT ELECTIVE ONE- AND TWO-LEVEL INSTRUMENTED PLIF USING PEDICLE SCREW SYSTEMS AND MESH CAGES WERE INCLUDED IN THE STUDY. THERE WERE 128 MALE AND 145 FEMALE PATIENTS WITH AN AVERAGE OF 60 YEARS OLD (RANGE 21 TO 90 YEARS). OF THESE PATIENTS, 140 WERE IMPLANTED WITH AN UNKNOWN DEPUY SPINE MOSS MIAMI SYSTEM PEDICLE SCREW COMBINED WITH UNKNOWN DEPUY SPINE HARMS CAGE (DEPUY-ACROMED, CLEVELAND, OH), 2 WERE IMPLANTED WITH A COMPETITOR¿S PEDICLE SCREW SYSTEM COMBINED WITH UNKNOWN DEPUY SPINE HARMS CAGE AND 2 WERE IMPLANTED WITH AN UNKNOWN DEPUY SPINE STEFFEE VARIABLE SPINE PLATING SYSTEM COMBINED WITH A COMPETITOR¿S CAGE. PATIENTS USED DICLOFENAC SODIUM FOR THE FIRST 2 WEEKS POST-PLIF. THE PATIENTS WERE DIVIDED INTO 3 GROUPS: GROUP 1=NO NSAID OR DICLOFENAC SODIUM USE, GROUP 2= 25 TO 300 MG OR APPROXIMATELY 2 DAYS WORTH OF DICLOFENAC SODIUM AT A RECOMMENDED DAILY DOSE OF 75 TO 150 MG/DAY, AND GROUP 3= GREATER THAN 300 MG OF DICLOFENAC SODIUM. POSTOPERATIVELY, ALL PATIENTS WERE PLACED ON BED REST AT LEAST FOR 24 HOURS AND ALLOWED TO UNDERGO PHYSICAL THERAPY AND PROGRESSIVE AMBULATION AS SOON AS TOLERATED. HARD LUMBAR CORSET BRACES WERE PRESCRIBED FOR ALL PATIENTS FOR AT LEAST 3 MONTHS. ALL PATIENTS WERE FOLLOWED-UP FOR AT LEAST 2 YEARS POSTSURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 23 MALE PATIENTS HAD DELAYED UNION. 2 MALE PATIENTS HAD NONUNION. THESE PATIENTS HAD USED MORE THAN 300 MG OF DICLOFENAC SODIUM WITHIN 2 WEEKS POSTOPERATIVELY. 18 FEMALE PATIENTS HAD DELAYED UNION. 2 FEMALE PATIENTS HAD NONUNION. THESE PATIENTS HAD USED MORE THAN 300 MG OF DICLOFENAC SODIUM WITHIN 2 WEEKS POSTOPERATIVELY. DEPUY SPINE PRODUCTS: THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE MOSS MIAMI PEDICLE SCREW SYSTEM (DEPUY-ACROMED, CLEVELAND, OH), UNKNOWN DEPUY SPINE HARMS CAGE (DEPUY-ACROMED, CLEVELAND, OH) AND UNKNOWN DEPUY SPINE STEFFEE VARIABLE SPINE PLATING SYSTEM (DEPUY- ACROMED). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 3 OF 8 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14991 UNKNOWN PLATES PLATE,FIXATION,BONE HRS MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention