BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ZERO-P

    MDR report key: 16983403 · Received May 23, 2023

    Report

    Report Number
    8030965-2023-06481
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    August 29, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    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. THIS REPORT IS FOR AN UNKNOWN - CONSTRUCTS: ZERO-P /UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. D10: 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HUANG, K. ET AL (2022), CERVICAL DISC ARTHROPLASTY COMBINED WITH TWO-LEVEL ACDF FOR THE TREATMENT OF CONTIGUOUS THREE-LEVEL CERVICAL DEGENERATIVE DISC DISEASE: A COMPARATIVE STUDY, JOURNAL OF ORTHOPAEDIC RESEARCH, 41 (XX), PAGES 1105¿1114 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE IN VIVO DIFFERENCES AMONG DIFFERENT HYBRID CONSTRUCTS WITH ONE-LEVEL CDA AND TWO-LEVEL ACDF. BETWEEN JUNE 2012 AND JULY 2020., A TOTAL OF 53 PATIENTS (29 PATIENTS IN THE TYPE A GROUP [12 MALES, 17 FEMALES WITH MEAN AGE OF 52.03 ± 7.76], 11 PATIENTS IN THE TYPE B GROUP [5 MALES, 6 FEMALES WITH MEAN AGE OF 49.55 ± 7.38], AND 13 PATIENTS IN THE TYPE C GROUP [9 MALES, 4 FEMALES WITH MEAN AGE OF 53.77 ± 10.10 THERE WERE NO SIGNIFICANT DIFFERENCES IN THE SEX RATIO, AVERAGE AGE, AVERAGE OPERATION TIME, OR AVERAGE BLOOD LOSS AMONG THE THREE GROUPS. A DIFFERENCE COULD BE OBSERVED IN THE DISTRIBUTION OF SURGICAL LEVELS AMONG GROUPS (P < 0.05). ACCORDING TO THE DIFFERENT NUMBERS OF CDAS AND ACDFS, THEY CLASSIFIED THREE-LEVEL HS INTO TWO TYPES: TYPE , ONE-LEVEL CDA AND TWO LEVEL ACDF; AND TYPE , TWO-LEVEL CDA AND ONE-LEVEL ACDF. THE PRESENT STUDY CONCENTRATED ON TYPE HS. IN TYPE HS, ACCORDING TO THE DIFFERENT LOCATIONS OF CDA AND ACDF, THEY ULTIMATELY DIVIDED THE CONSTRUCTS INTO THREE SUBTYPES: TYPE A: CDA WAS PERFORMED AT THE SUPERIOR LESION SEGMENT, AND ACDF WAS PERFORMED AT THE INTERMEDIATE AND INFERIOR LESION SEGMENTS; TYPE B: CDA WAS PERFORMED AT THE INTERMEDIATE LESION SEGMENT, AND ACDF WAS PERFORMED AT THE SUPERIOR AND INFERIOR LESION SEGMENTS; TYPE C: CDA WAS PERFORMED AT THE INFERIOR LESION SEGMENT, AND ACDF WAS PERFORMED T THE SUPERIOR AND INTERMEDIATE LESION SEGMENTS. THE PRODUCTS WERE USED IN SURGERY INCLUDING ONE-LEVEL CDA PERFORMED WITH A PRESTIGE-LP SYSTEM (MEDTRONIC SOFAMOR DANEK) AND TWO-LEVEL ACDF PERFORMED WITH THE CONVEX ZERO-P IMPLANT SYSTEM (SYNTHES). THE MEAN FOLLOW-UP TIMES OF EACH GROUP WERE 39.68, 40.65, AND 37.13 MONTHS, RESPECTIVELY. THE FOLLOWING THE COMPLICATIONS REPORTED AS FOLLOWS: A GROUP: - 8 PATIENTS WITH DYSPHAGIA AFTER SURGERY AND RECOVERED WITHIN 6 MONTHS - 2 PATIENTS RECEIVED REVISION SURGERY DUE TO ASD DURING THE FOLLOW-UP PERIOD - HETEROTOPIC OSSIFICATION WAS FOUND IN 12 PATIENTS AT FINAL FOLLOW-UP B GROUP: - 3 PATIENTS WITH DYSPHAGIA AFTER SURGERY AND RECOVERED WITHIN 6 MONTHS - HETEROTOPIC OSSIFICATION WAS FOUND IN 5 PATIENTS AT FINAL FOLLOW-UP C GROUP: - 4 PATIENTS WITH DYSPHAGIA AFTER SURGERY AND RECOVERED WITHIN 6 MONTHS. - HETEROTOPIC OSSIFICATION WAS FOUND IN 7 PATIENTS AT FINAL FINAL FOLLOW-UP THIS REPORT IS FOR AN UNKNOWN CONVEX ZERO-P IMPLANT SYSTEM (DEPUY SYNTHES). THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217798 UNK - CONSTRUCTS: ZERO-P ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention