BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MESH

    MDR report key: 6680574 · Received June 30, 2017

    Report

    Report Number
    2520274-2017-11907
    Event Type
    Injury
    Date Received
    June 30, 2017
    Report Date
    June 12, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    EZX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. HARTMANN, S; ET AL (2017) RETROSPECTIVE ANALYSIS OF CERVICAL CORPECTOMIES: IMPLANT-RELATED COMPLICATIONS OF ONE- AND TWO-LEVEL CORPECTOMIES IN 45 PATIENTS. NEUROSURG REV ¿ 6 PAGES. THIS REPORT IS FOR AN UNKNOWN SYNMESH (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: HARTMANN, S; ET AL (2017) RETROSPECTIVE ANALYSIS OF CERVICAL CORPECTOMIES: IMPLANT-RELATED COMPLICATIONS OF ONE- AND TWO-LEVEL CORPECTOMIES IN 45 PATIENTS. NEUROSURG REV ¿ 6 PAGES. THIS IS A RETROSPECTIVE ANALYSIS OF 45 CONSECUTIVE PATIENTS TREATED BY AN ANTERIOR CERVICAL CORPECTOMY AND GRAFT RECONSTRUCTION WITH PLATING BETWEEN 2011 AND 2014. THE MEAN AGE WAS 60 (±11) YEARS, WITH A FEMALE TO MALE SEX RATIO OF 19 TO 26, RESPECTIVELY. DUE TO THE RETROSPECTIVE CHARACTER OF THE PRESENT STUDY, A MINIMUM FOLLOW-UP FOR ALL PATIENTS OF 12 MONTHS TO A MAXIMUM FOLLOW-UP OF 55 MONTHS. THE MAJORITY OF THE PATIENTS WERE TREATED WITH A TITANIUM MESH CAGE SYSTEM (TMC; SYNMESH¿ VERTEBRAL BODY REPLACEMENT SYSTEM, DEPUY SYNTHES. A SEMI-CONSTRAINED SCREW/PLATE SYSTEM WITH SELF-DRILLING SCREWS OF UP TO 20° ANGULATION (SKYLINE¿ ANTERIOR CERVICAL PLATE SYSTEM, DEPUY SYNTHES©) WAS APPLIED AFTER CORPECTOMY. TRABIS (COLIGNE) CAGE WAS USED IN 2 PATIENTS. TEN PATIENTS (22.2%) EXPERIENCED A POSTOPERATIVE COMPLICATION. TWO PATIENTS (4.4%) HAD A POST-OPERATIVE HAEMATOMA AND ANOTHER TWO PATIENTS (4.4%) SUFFERED FROM NEUROLOGICAL DETERIORATION DUE TO ONGOING AND SEVERE MYELOPATHIC SYMPTOMS. ALL FOUR PATIENTS RECEIVED REVISION SURGERY INCLUDING EVACUATION OF THE HAEMATOMA OR FURTHER DECOMPRESSION OF NEURAL STRUCTURES. THE REMAINING SIX PATIENTS HAD A CONSTRUCT FAILURE WITHIN THE FIRST WEEKS AFTER SURGERY (MEAN 90 DAYS AFTER SURGERY), SO THAT AN OVERALL IMPLANT-RELATED COMPLICATION RATE OF 13.3% COULD BE OBSERVED. ALL OF THE SIX PATIENTS WITH IMPLANT-RELATED FAILURES WERE TREATED WITH AN ANTERIOR-ONLY PROCEDURE. THERE WAS ISOLATED LOOSENING OR TOGGLING OF THE ANTERIOR LOWER SCREWS IN THREE PATIENTS (50%). ANOTHER THREE PATIENTS (50%) SUFFERED FROM CAGE SUBSIDENCE INTO THE CAUDAL VERTEBRAL BODY (ONE PATIENT) AND GRAFT DISPLACEMENT WITH KICKING OUT OF THE GRAFT/PLATE ANTERIORLY (TWO PATIENTS) DUE TO CAUDAL/LOWER SCREW PULL-OUT. ALL PATIENTS WITH IMPLANT RELATED COMPLICATIONS NEEDED REVISION SURGERY INCLUDING ANTERIOR RE-INSTRUMENTATION WITH AN ADDITIONAL DORSAL SUPPORT. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNMESH AND REFERS TO THE SERIOUS INJURY / REPORTABLE MALFUNCTION OF 6 UNKNOWN PATIENT WHO EXPERIENCED IMPLANT RELATED FAILURES WITH REVISION: 3 HAD SCREW LOOSENING /TOGGLING, 3 HAD CAGE SUBSIDENCE (1 HAD GRAFT DISPLACEMENT, 2 SCREW PULL OUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463396 SURGICAL MESH EZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention