BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGRAFT (IMPLANT)

    MDR report key: 280378 · Received May 23, 2000

    Report

    Report Number
    MW1019037
    Event Type
    Injury
    Date Received
    May 23, 2000
    Date of Event
    May 12, 2000
    Report Date
    May 15, 2000
    Manufacturer
    GENSCI REGENERATION LABORATORIES, INC.
    Product Code
    LMO
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/21/00: RESPONSIVE TO ITEM NUMBER ONE (1), COMMUNICATION WITH THE REPORTING FACILITY INDICATED THAT THE GELATINOUS MATERIAL WAS SENT FOR PATHOLOGICAL TESTING TO ITS OWN LAB; NO SAMPLE WAS AVAILABLE FOR MFR TO EVALUATE. WITH THE EXCEPTION OF A STATEMENT THAT "THERE WERE NO OTHER REMARKABLE FEATURES," THE USER FACILITY'S PATHOLOGY REPORT CONTAINED THE SAME INFO INCLUDED IN THE VOLUNTARY MEDWATCH REPORT. ALTHOUGH IT HAD NOT BEEN REVEALED IN MFR'S CONTACT WITH THE REPORTING FACILITY, FURTHER REVIEW OF THE PATHOLOGY REPORT, INDICATED THAT TISSUE HAD ALSO BEEN SUBMITTED FOR BACTERIOLOGIC STUDIES. AS THE REPORTING FACILITY HAS NOT YET PROVIDED MFR WITH THESE RESULTS, MFR IS CONTINUING THEIR EFFORTS TO OBTAIN THIS INFO. AN INTERNAL INVESTIGATION WAS PERFORMED WITH THE FOLLOWING RESULTS: VISUAL INSPECTION OF THE ARCHIVED UNITS FOR THE REPORTED SERIAL NUMBERS SHOWED THEM TO MEET PRODUCT AND PACKAGING INTEGRITY SPECS. REVIEW OF THE BATCH RECORDS FOR DONOR INFECTIOUS DISEASE TESTING AND VARIOUS BACTERIAL AGENTS CONFIRMED THE LOTS TO CONFORM TO SPECS. IN ADDITION, REVIEW OF THE MFG PROCESS REVEALED NO DEVIATIONS FROM SPECS. ARCHIVE SAMPELS FROM THE TWO LOTS WERE SENT TO AN INDEPENDENT LAB FOR KINETIC-CHROMOGENIC LIMULUS AMEBOCYTE LYSATE (LAL) AND BIOBURDEN (AEROBIC, ANAEROBIC, AND FUNGI) TESTING; ALL TEST RESULTS WERE NEGATIVE. NO COMPLAINT REPORTS OR GRAFT TRACING RECORDS RELATED TO OTHER UNITS OF EITHER LOT HAVE BEEN RECEIVED TO DATE. BASED UPON THE RESULTS OF INVESTIGATION, MFR DOES NOT BELIEVE THAT ITS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PLEASE NOTE THAT LETTER, AND THE REPORT ATTACHED TO IT, REPEATEDLY REFERS TO PRODUCT AS A "DEVICE", MFR WOULD LIKE TO POINT OUT THAT THIS PRODUCT FALLS UNDER THE CATEGORY OF HUMAN TISSUE INTENDED FOR TRANSPLANTATION AND IS THEREFORE REGULATED UNDER 21 CFR PART 1270. WHILE MEDWATCH REPORTING IS NOT REQUIRED FOR HUMAN TISSUE INTENDED FOR TRANSPLANTATION, MFR IS INCLUDING WITH THIS CORRESPONDENCE THE FOLLOWING DISCLAIMER COMMON TO SUBMISSIONS OF THIS NATURE. THE FOLLOWING DISCLAIMER SHOULD BE INCLUDED WITH ANY AND ALL COPIES OF THE INFO DISSEMINATED TO ANY SOURCE: SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT." FORWARD THIS COMPLETE REPORT W/MFR RESPONSE TO CBER. THIS PRODUCT IS NOT A DEVICE.

    Description of Event or Problem · 1

    AFTER LUMBAR FUSION, THIS PRODUCT WAS INTRODUCED INTO SPACE TO PROVIDE MATRIX FOR BONE GROWTH STABILIZATION OF FUSION. LESS THAN 1 MONTH LATER, PT RETURNED TO SURGERY WITH AREA OF INCISION REDDENED. WHEN AREA WAS EXPOSED, NON-UNION OF TISSUE NOTED ALL THE WAY THROUGH MUSCLE LAYER. SURGEON REMOVED AT BASE OF INCISION A GELATINOUS, GRAY COLORED GLOBULE RESEMBLING GRAFTING MATERIAL INSERTED. NOT AN EXPECTED FINDING AT THIS POINT. TWO CONTAINERS OF MATERIAL WERE USED ON THIS PT. GELATINOUS MATERIAL REMOVED WITH PT WOUND HEALING NOW PROGRESSING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAGRAFT (IMPLANT) * LMO GENSCI REGENERATION LABORATORIES, INC. * AL990312046
    2 DYNAGRAFT (IMPLANT) * LMO GENSCI REGENERATION LABORATORIES, INC. * AL1991042002

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R