BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ZERO-P

    MDR report key: 15124492 · Received July 28, 2022

    Report

    Report Number
    8030965-2022-05375
    Event Type
    Injury
    Date Received
    July 28, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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. DATE OF EVENT: UNKNOWN EVENT DATE. THIS REPORT IS FOR AN UNKNOWN ZERO P CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE OF EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR AND MANUFACTURE DATE: 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: WEI L., ET AL (2022) APPLICATION OF A NEW INTEGRATED LOW-PROFILE ANTERIOR PLATE AND CAGE SYSTEM IN SINGLE-LEVEL CERVICAL SPONDYLOSIS: A PRELIMINARY RETROSPECTIVE STUDY, JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH VOLUME 17, PAGES 1-8 (CHINA). THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF A NEW INTEGRATED LOW-PROFILE ANTERIOR PLATE AND CAGE SYSTEM (CARMEN, SHANGHAI SANYOU MEDICAL CO., LTD, SHANGHAI, CHINA) FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) IN TREATING CERVICAL SPONDYLOSIS WITH THE ZERO-PROFILE IMPLANT.BETWEEN JANUARY 2018 AND JANUARY 2020, PATIENTS WHO UNDERWENT SINGLELEVEL ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) FOR DIAGNOSED CERVICAL RADICULOPATHY OR MYELOPATHY WERE REVIEWED. 28 PATIENTS (15 MALES AND 13 FEMALES) 47.2 ± 6.7 YEARS WHO UNDERWENT SINGLELEVEL ACDF WITH THE NEW LOW-PROFILE ANTERIOR PLATE AND CAGE SYSTEM (CARMEN, SHANGHAI SANYOU MEDICAL CO., LTD, SHANGHAI, CHINA) IS INCLUDED IN THIS STUDY, AND 68 PATIENTS (36 MALES AND 32 FEMALES) AGE 48.7 ± 7.3 YEARS WITH ZERO-P (DEPUY SYNTHES, USA) FOR SINGLE-LEVEL ACDF SYMPTOMATIC CERVICAL SPONDYLOSIS WERE ENROLLED IN THIS STUDY. THE NEW INTEGRATED LOW-PROFILE IMPLANT CARMEN WAS FIRST USED IN 2018 , AND WAS USED IN 28 PATIENTS UNTIL JANUARY 2020 (ALL PATIENTS WERE DIAGNOSED AS SINGLE-LEVEL CERVICAL SPONDYLOSIS, AND WERE DEFINED AS CARMEN GROUP IN THE FOLLOWING STUDY). 68 PATIENTS WHO RECEIVED SINGLELEVEL ACDF WITH ZERO-P DEVICE WERE DEFINED AS ZERO-P GROUP. ALL PATIENTS WERE FOLLOWED UP REGULARLY, WITH THE MEAN FOLLOW-UP TIME OF 15.19 MONTHS (FROM 12 TO 24). REPORTED COMPLICATIONS: THE INCIDENCE OF POSTOPERATIVE DYSPHAGIA OCCURRED IN 2 IN ZERO P GROUP. ALL THESE PATIENTS HAD NO SYMPTOM AT 6-MONTH FOLLOWUP, AND NO PATIENT SUFFERED SEVERE DYSPHAGIA. FOR ADJACENT SEGMENT DEGENERATION, 5 PATIENTS IN ZERO-P GROUP BUT NO SIGNIFICANT COMPRESSION AND NEUROLOGICAL SYMPTOMS OCCURRED. 2 PATIENTS IN ZERO-P GROUP SUFFERED POSTOPERATIVE AXIAL PAIN AFTER THE SURGERY, AND RECOVERED WITHIN 6-MONTH. 1 PATIENT HAD PSEUDOARTHROSIS IN ZERO-P GROUP AND DID NOT ACHIEVE FUSION UNTIL 12-MONTH POST-OPERATION.WITH THAT FUSION RATE FOR ZERO P GROUP IS 98.5 PERCENT. POSTOPERATIVE CERVICAL AND SEGMENTAL COBB ANGLE WERE BETTER MAINTAINED IN THE NEW LOW-PROFILE IMPLANT GROUP COMPARED TO ZERO-P GROUP. WHERE THE CERVICAL COBB ANGLE WAS 15.33 ± 4.42 AT POSTOPERATION (3 DAYS) AND 12.53 ± 4.42 AT POSTOPERATION (12 M). SEGMENTAL COBB ANGLE WAS 5.73 ± 1.57 AT POSTOPERATION (3 DAYS) AND 4.19 ± 1.18 AT POSTOPERATION (12 M) IN ZERO P GROUP. REPRESENTATIVE CERVICAL X-RAY IMAGES OF ZERO-P IMPLANT TREATED PATIENT: SINGLE-LEVEL MALE PATIENT TREATED WITH ZERO-P DEVICE, THE SEGMENTAL COBB ANGLE OF C5¿C6 CHANGED FROM 7-DEGREE LORDOSIS TO 9-DEGREE LORDOSIS AFTER THE SURGERY, AND DECREASED TO 4-DEGREE AT ONE-YEAR FOLLOW-UP, AS WELL AS THE C2¿C7 COBB ANGLE (15-DEGREE PREOPERATIVE, 20-DEGREE POSTOPERATIVE AND 15-DEGREE AT ONE-YEAR FOLLOW-UP) . THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SYNTHES ZERO-P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286375 UNK - CONSTRUCTS: ZERO-P INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention