BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIGIS-R LARGE

    MDR report key: 6164742 · Received December 9, 2016

    Report

    Report Number
    3005619263-2016-00055
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    UDI-DI
    00643169624795
    PMA / PMN Number
    K150291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ENVELOPE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED PRODUCT INDICATED AN ISSUE WITH THE DEVICE ENVELOPE APPEARANCE. THERE WAS A PARTICLE LOCATED ON THE INTERIOR SURFACE OF THE ENVELOPE. THE PARTICLE HAD A DARK AND GLASSY APPEARANCE IN THE OPTICAL IMAGES. THE PARTICLE WAS ABOUT 1MM IN LENGTH. THE SAMPLE WAS SENT TO THE LAB TO DETERMINE THE ORIGIN OF THE FOREIGN MATTER. THE UNKNOWN RESIDUE WAS THOROUGHLY CHARACTERIZED BY INFRARED SPECTROSCOPY AND TIME-OF-FLIGHT SECONDARY ION MASS SPECTROMETRY (TOF-SIMS). THE RESULTS SUGGEST THE UNKNOWN MATERIAL FROM THE FIELD RETURN IS SIMILAR TO MATERIAL FROM THE SPRAYING/DRYING OVEN, AND IS COMPOSED OF A MIXTURE OF THK AFA GREASE AND ACTIVE PHARMACEUTICAL INGREDIENT (API) COATING. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: LOT# 16H15753 - THE PARTICLE WAS LOCATED ON THE INTERIOR SURFACE OF THE ENVELOPE. THE PARTICLE HAD A DARK AND GLASSY APPEARANCE IN THE OPTICAL IMAGES. THE PARTICLE WAS ABOUT 1MM IN LENGTH. THE SAMPLE WAS SENT TO THE LAB TO DETERMINE THE ORIGIN OF THE FOREIGN MATTER. THE UNKNOWN RESIDUE WAS THOROUGHLY CHARACTERIZED BY INFRARED SPECTROSCOPY AND TOF-SIMS. THE RESULTS SHOW THE UNKNOWN MATERIAL FROM THE FIELD RETURN IS SIMILAR TO MATERIAL FROM THE SPRAYING, AND IS COMPOSED OF A MIXTURE OF THK AFA GREASE AND API COATING (TYROSINE POLYMER, MINOCYCLINE AND RIFAMPIN). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE ABSORBABLE ENVELOPE WAS OPENED AND FOUND TO HAVE A VISIBLE ANOMALY ON THE ENVELOPE, A BLACK SPEC. THE ENVELOPE WAS INSPECTED BEFORE GOING TO THE STERILE FIELD BY THE IMPLANTING PHYSICIAN WHO DETERMINED IT SHOULD BE DISCARDED. ANOTHER ENVELOPE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814548 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. NMRM6133 16H15753 00643169624795

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR