BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 9928843 · Received April 6, 2020

    Report

    Report Number
    1416980-2020-01987
    Event Type
    Injury
    Date Received
    April 6, 2020
    Report Date
    May 1, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIAN AGE: 61 YEARS. FEMALES-8, MALES-12. EVENT DATE: THE STUDY WAS CONDUCTED FROM OCTOBER 2010 TO MARCH 2012. LITERATURE ARTICLE: BILLE, A., OKIROR, W., KARENOVICS,W. , ROUTLEDGE, T. ¿EXPERIENCE WITH TITANIUM DEVICES FOR RIB FIXATION AND COVERAGE OF CHEST WALL DEFECTS¿. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 15 (2012) 588¿595. ADVANCE ACCESS PUBLICATION 19 JULY 2012. DOI:10.1093/ICVTS/IVS327. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX PATIENTS UNDERWENT AN 18-MONTH STUDY IN WHICH VERITAS WAS USED FOR DEFECTS IN THE CHEST WALL THAT WERE LARGER THAN 6 CM OR 3 OR WHERE MORE RIBS WERE RESECTED. TWO PATIENTS UNDERWENT SURGERY FOR LUNG HERNIATION AFTER SPONTANEOUS RIB FRACTURES. THE VERITAS PATCH WAS USED TO CLOSE THE GAP BETWEEN THE RIBS. BOTH PATIENTS DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATIONS AND WERE DISCHARGED AFTER THREE DAYS. IT WAS REPORTED ONE OF THE PATIENT¿S EXPERIENCED A RECURRENCE AFTER FOUR MONTHS. THE CHEST WALL WAS REPAIRED WITH A NON-BAXTER MESH. THE SECOND PATIENT EXPERIENCED A RECURRENCE TWO MONTHS LATER. THE REPAIR SURGERY WAS POSTPONED DUE TO AN UNRELATED INDICATION. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOMES WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394567 VERITAS MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STRATOS CLIPS| SYNTHES PLATE