BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUGMENT® INJECTABLE

    MDR report key: 12418410 · Received September 2, 2021

    Report

    Report Number
    3003897776-2021-00004
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    June 25, 2021
    Report Date
    December 7, 2021
    Manufacturer
    BIOMIMETIC THERAPEUTICS, LLC
    Product Code
    NOX
    UDI-DI
    10859477002140
    PMA / PMN Number
    P100006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. INSTRUCTIONS REQUIRE THE CUSTOMER TO INTRODUCE THE PDGF LIQUID INTO THE SHREDDED MATRIX SOLIDS. THE MATERIAL SHOULD THEN "SIT/REST" FOR A SPECIFIED AMOUNT OF TIME TO ALLOW THE SOLIDS TO BE FULLY WETTED/HYDRATED BEFORE PROCEEDING TO FURTHER MIXING STEPS. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON ASKED FOR A 3CC KIT. ONE WAS BROUGHT INTO THE ROOM. THE PREMIX PROCEDURE WAS FOLLOWED. THE MATERIAL DID NOT RECONSTITUTE CORRECTLY, IT REMAINED ALMOST LIKE A POWDER AFTER THE FLUID WAS MIXED. SURGEON WAS UNABLE TO USE THE GRAFT AS IT WOULD NOT HOLD IN PLACE IN THE JOINT. ANOTHER 3CC KIT WAS NOT IN HOUSE SO TWO 1.5CC GRAFTS WERE USED AND RECONSTITUTED. BOTH OF THEM RECONSTITUTED JUST FINE AND WERE ABLE TO UTILIZE THEM. THE SURGEON FELT IT WAS A DEFECT IN PERHAPS THE FLUID OR SOMETHING THAT CAUSED THE FIRST FAILURE TO RECONSTITUTE AND DID NOT WANT THE PATIENT CHARGED FOR THE 3CC GRAFT. 2X 1.5CC AUGMENT INJECTABLE WERE USED. THE IMPACT TO THE PATIENT WAS ADDED TIME UNDER ANESTHESIA AND THEIR EXPENSE.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ASKED FOR A 3CC KIT. ONE WAS BROUGHT INTO THE ROOM. THE PREMIX PROCEDURE WAS FOLLOWED. THE MATERIAL DID NOT RECONSTITUTE CORRECTLY, IT REMAINED ALMOST LIKE A POWDER AFTER THE FLUID WAS MIXED. SURGEON WAS UNABLE TO USE THE GRAFT AS IT WOULD NOT HOLD IN PLACE IN THE JOINT. ANOTHER 3CC KIT WAS NOT IN HOUSE SO TWO 1.5CC GRAFTS WERE USED AND RECONSTITUTED. BOTH OF THEM RECONSTITUTED JUST FINE AND WERE ABLE TO UTILIZE THEM. THE SURGEON FELT IT WAS A DEFECT IN PERHAPS THE FLUID OR SOMETHING THAT CAUSED THE FIRST FAILURE TO RECONSTITUTE AND DID NOT WANT THE PATIENT CHARGED FOR THE 3CC GRAFT. 2X 1.5CC AUGMENT INJECTABLE WERE USED. THE IMPACT TO THE PATIENT WAS ADDED TIME UNDER ANESTHESIA AND THEIR EXPENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310896 AUGMENT® INJECTABLE FILLER, BONE VOID, CALCIUM COMPOUND NOX BIOMIMETIC THERAPEUTICS, LLC K30003010 1709000 10859477002140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown