BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 10449343 · Received August 25, 2020

    Report

    Report Number
    1526439-2020-01527
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    July 30, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN PLATE/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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GANDHI, S.D. ET AL. (2020), EFFECT OF LOCAL RETROPHARYNGEAL STEROIDS ON FUSION RATE AFTER ANTERIOR CERVICAL DISCECTOMY AND FUSION, THE SPINE JOURNAL, VOL. 20, ISSUE 2, PAGES 261-265 (USA). THE PURPOSE OF THIS STUDY IS TO EXAMINE THE EFFECT OF RETROPHARYNGEAL STEROIDS ON FUSION RATE AND REVISION SURGERY AFTER ACDF. BETWEEN DECEMBER 2013 AND JANUARY 2015, 121 PATIENTS UNDERWENT 1, 2 OR 3 LEVEL ACDFS USING ANTERIOR CERVICAL PLATES WITH VARIABLE ANGLE SCREWS (SKYLINE CERVICAL SYSTEM, DEPUY SYNTHES, RAYNHAM, MA). THE PATIENTS WERE DIVIDED INTO 2 GROUPS. 34 PATIENTS IN THE EXPERIMENTAL GROUP AND 55 PATIENTS IN THE CONTROL GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE EXPERIMENTAL GROUP HAD AN OVERALL FUSION RATE OF 64.7%, WHEREAS THE CONTROL GROUP HAD A FUSION RATE OF 91%. 1 PATIENT DEVELOPED AN ESOPHAGEAL RUPTURE AND RETROPHARYNGEAL ABSCESS, REQUIRING SURGICAL IRRIGATION, DEBRIDEMENT, AND REPAIR 8 MONTHS POSTOPERATIVELY. 12 PATIENTS HAD CAUSE REOPERATIONS. 5 PATIENTS HAD REOPERATION FOR PSEUDOARTHROSIS. THIS REPORT IS FOR AN UNKNONW SYNTHES ANTERIOR CERVICAL PLATE (SKYLINE CERVICAL SYSTEM) THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915324 UNKNOWN PLATES PLATE,FIXATION,BONE HRS MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention