BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ZIPFIX IMPLANTS

    MDR report key: 16311876 · Received February 7, 2023

    Report

    Report Number
    8030965-2023-01479
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    February 3, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 ZIPFIX IMPLANT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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, A FOLLOW-UP WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TAM JKC, ET AL. (2022), NOVEL NUSS BAR FIXATION USING ZIPFIX FOR PECTUS EXCAVATUM, HEART, LUNG AND CIRCULATION, 31, 889¿893, HTTPS://DOI.ORG/10.1016/J.HLC.2021.12.012, (SINGAPORE). THIS STUDY REPORTS ON A NOVEL METHOD OF BAR FIXATION USING ZIPFIX, A BIOCOMPATIBLE CABLE-TIE IMPLANT, AND SHARES A SERIES OF PATIENTS AND OUTCOMES. BETWEEN JULY 2015 AND SEPTEMBER 2020, 20 PATIENTS WITH SIGNIFICANT PECTUS EXCAVATUM WHO UNDERWENT A NUSS PROCEDURE WITH ZIPFIX WERE INCLUDED IN THIS STUDY. THERE WERE 19 MALES AND 1 FEMALE, AND THE MEAN AGE OF ALL PATIENTS WAS 22 YEARS (RANGE, 16¿38). THE PATIENTS UNDERWENT NUSS BAR PROCEDURE AND WERE IMPLANTED WITH A COMPETITOR¿S NUSS BAR (MANUFACTURER: UNKNOWN) THAT WERE STABILIZED USING THE UNKNOWN SYNTHES ZIPFIX. 6 PATIENTS HAD 1 ZIPFIX PLACED AND 14 PATIENTS HAD 2 ZIPFIX IMPLANTED. AS PER INSTITUTION PRACTICE, THE BAR AND ZIPFIX ARE REMOVED 2¿3 YEARS AFTER THE IMPLANTATION. COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT 4, A 23-YEAR-OLD MALE HAD BILATERAL WOUND DEHISCENCE AFTER REMOVAL REQUIRING LEFT VACUUM-ASSISTED DRAINAGE AND SECONDARY CLOSURE. PATIENT 11, A 19-YEAR-OLD MALE HAD (2) ZIPFIX ON RIGHT DEVELOPED LEFT EMPYEMA REQUIRING DRAINAGE AND DECORTICATION. PATIENTS 12, A 19-YEAR-OLD MALE HAD POST IMPLANTATION RIGHT SUPERFICIAL WOUND INFECTION WHICH WAS CONSERVATIVELY MANAGED. THIS REPORT IS FOR AN UNK - ZIPFIX IMPLANT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495082 UNK - ZIPFIX IMPLANTS CERCLAGE, FIXATION JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other