BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ZERO-P

    MDR report key: 16998330 · Received May 24, 2023

    Report

    Report Number
    8030965-2023-06627
    Event Type
    Injury
    Date Received
    May 24, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNK - CONSTRUCTS: ZERO-P/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: IBRAHIM, M.Z., RAHMAN, A.F. AND ZAHLAWY, H.E. (2022) ZERO-PROFILE IMPLANT VERSUS INTEGRATED CAGE-PLATE IMPLANT IN TREATMENT OF SINGLE LEVEL CERVICAL DISC DISEASE, ACTA ORTHOPÆDICA BELGICA, VOL. 88 (XX), PAGES 285-291 (EGYPT) THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE AND COMPARE THE CLINICAL AND RADIOLOGICAL RESULTS OF THE USE OF ZERO-P IMPLANT AND THE INTEGRATED CAGE-PLATE IMPLANT IN SURGICAL TREATMENT OF SINGLE LEVEL CERVICAL DISC DISEASE. BETWEEN AUGUST 2015 TO MARCH 2018, A TOTAL OF 54 PATIENTS UNDERWENT SINGLE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION. THE PATIENTS WERE DIVIDED INTO 2 GROUPS. GROUP (A) CONSISTS OF 28 PATIENTS (15 FEMALE AND 13 MALE) WITH A MEAN AGE OF 49.5±11 YEARS WAS OPERATED WITH ZERO-PROFILE IMPLANT (ZERO-P, SYNTHES GMBH SWITZERLAND, OBERDORF, SWITZERLAND), AND GROUP (B) CONSISTS OF 26 PATIENTS (15 FEMALE AND 11 MALE) WITH A MEAN AGE OF 49.8±11.6 YEARS WAS OPERATED WITH A COMPETITOR DEVICE. ALL PATIENTS SHOWED SIGNS OF FUSION AT THE FINAL FOLLOW UP WITH NO CASE OF PSEUDOARTHROSIS OR IMPLANT FAILURE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: N=3 PATIENTS HAD IMMEDIATE POSTOPERATIVE DYSPHAGIA (ALL OF THEM WERE MODERATE, 2 PERFORMED SURGERY AT C5/6 LEVEL AND 1 AT C6/7), BUT NO PATIENT HAD PERSISTENT DYSPHAGIA BEYOND THE FIRST POSTOPERATIVE MONTH. THIS REPORT IS FOR AN UNKNOWN SYNTHES SPINE ZERO-PROFILE. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: ZERO-P. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569934 UNK - CONSTRUCTS: ZERO-P ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention