BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ANTERIOR CERVICAL LOCKING PLATE

    MDR report key: 16978699 · Received May 22, 2023

    Report

    Report Number
    8030965-2023-06455
    Event Type
    Injury
    Date Received
    May 22, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: A1, A2, A3, A4: THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. D1, D2, D3, D4, G4 - 510K: THIS REPORT IS FOR AN UNKNOWN ANTERIOR CERVICAL LOCKING PLATE CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D6: THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN NOVEMBER 2009 AND OCTOBER 2013. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: THIND, H. ET AL. (2022), 2-LEVEL ANTERIOR CERVICAL ARTHRODESIS WITH INTEGRATED SPACER AND PLATE VS TRADITIONAL ANTERIOR SPACER AND PLATE SYSTEM, INTERNATIONAL JOURNAL OF SPINE SURGERY, VOL. 16 (02), PAGES 215¿221 (USA) THE AIM OF THIS STUDY WAS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF PATIENTS AFTER 2-LEVEL ACDF WITH ISP VS ASPS. BETWEEN NOVEMBER 2009 TO OCTOBER 2013, A TOTAL OF 84 PATIENTS WERE IDENTIFIED WHO UNDERWENT DE NOVO 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF): 43 PATIENTS RECEIVED INTEGRATED SPACER AND PLATE (ISP) AND 41 PATIENTS RECEIVED ANTERIOR SPACER AND PLATE SYSTEM (ASPS). IN THE ISP GROUP, AVERAGE PATIENT AGE WAS 54.8 ± 8.8 YEARS WITH (22 FEMALE AND 21 MALE). IN THE ASPS GROUP, AVERAGE AGE WAS 58.1 ± 11.5 YEARS WITH (18 FEMALE AND 23 MALE). ALL PATIENTS UNDERWENT THE SMITH-ROBINSON ANTERIOR APPROACH FOR CERVICAL DISCECTOMY AND FUSION IN THE SUBAXIAL SPINE (C3-C7). THE ISP GROUP WAS IMPLANTED WITH THE 2-SCREW POLYETHER ETHER KETONE CAGE WITH INTEGRATED PLATE SYSTEM PACKED WITH LOCAL AUTOGRAFT USING A COMPETITOR DEVICE AND THE ASPS GROUP WAS IMPLANTED WITH TRICORTICAL ALLOGRAFT INTERBODY SPACER WITH ACP (CERVICAL SPINE LOCKING PLATE, DEPUY SYNTHESE SPINE, INC., RAYNHAM, MA, USA). THE FOLLOWING COMPLICATIONS WERE REPORTED: ASPS GROUP: ¿ N=7 PATIENTS EXPERIENCED DYSPHAGIA ¿ N=1 PATIENT EXPERIENCED LONG-TERM DYSPHAGIA (>3 MONTHS) ¿ N=2 PATIENTS EXPERIENCED HORNER SYNDROME ¿ N=1 PATIENT HAD AN ADDITIONAL SURGERY UNRELATED TO THEIR INITIAL SURGERY ¿ N=1 PATIENT EXPERIENCED PSEUDOFUSION ¿ N=1 PATIENT EXPERIENCED NEURAPRAXIA THIS REPORT IS FOR AN UNKNOWN SYNTHESE SPINE CERVICAL SPINE LOCKING PLATE 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
    863012 UNK - CONSTRUCTS: ANTERIOR CERVICAL LOCKING PLATE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention