BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: CERVIOS

    MDR report key: 11806576 · Received May 11, 2021

    Report

    Report Number
    8030965-2021-03822
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    May 28, 2020
    Report Date
    April 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    ODP
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACERS: CERVIOS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: MOO, I.H. ET AL. (2020), A COMPARISON OF CONTIGUOUS TWO-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION USING A STRUCTURAL ALLOGRAFT VERSUS A POLYETHERETHERKETONE (PEEK) CAGE: THE RESULTS OF A THREE-YEAR FOLLOW-UP, BMC MUSCULOSKELETAL DISORDERS, VOL. 21:133, PAGES 1-8 (SINGAPORE). THE PRIMARY AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF TWO-LEVEL ACDF WITH PLATE FIXATION USING EITHER A STRUCTURAL ALLOGRAFT OR A PEEK CAGE. FROM 2010 TO 2015, 88 PATIENTS UNDERWENT TWO-LEVEL ACDF, OF WHOM 53 PATIENTS RECEIVED AN ALLOGRAFT AND 35 PATIENTS RECEIVED A PEEK CAGE. THERE WERE 19 MALES AND 15 FEMALES WITH A MEAN AGE OF 56.0 YEARS IN THE PEEK GROUP. IMPLANTS USED WERE CORNERSTONE®, MEDTRONIC SOFAMOR-DANEK, MEMPHIS, TN, USA; CERVIOS®, SYNTHES, ZUCHWIL, SWITZERLAND; SOLIS® STRYKER SPINE, ALLENDALE, NJ. ALL CLINICAL OUTCOMES WERE PROSPECTIVELY COLLECTED BEFORE AND SIX MONTHS AND TWO YEARS AFTER SURGERY. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: 8 PATIENTS HAD CAGE SUBSIDENCE AT CEPHALAD LEVEL. 13 PATIENTS HAD CAGE SUBSIDENCE AT CAUDAL LEVEL. THIS REPORT IS FOR AN UNKNOWN SYNTHES CERVIOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701651 UNK - CAGE/SPACERS: CERVIOS INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1