BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNABLAST PUTTY 5CC

    MDR report key: 2318918 · Received October 28, 2011

    Report

    Report Number
    3005990499-2011-00051
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    September 27, 2011
    Report Date
    October 6, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CONTRACT MFG FOR KEYSTONE DENTAL BY INTEGRA LIFESCIENCES. KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM INTEGRA LIFESCIENCES, THE DEVELOPER OF THE PRODUCT. A REVIEW OF KEYSTONE DENTAL INC AND INTEGRA LIFESCIENCES COMPLAINT DATABASES REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. INTEGRA LIFESCIENCES CONDUCTED A REVIEW OF THE BATCH RECORDS FOR DYNABLAST LOT 101109. THE RESULTS REVEALED THIS PRODUCT WAS MFG AND RELEASED IN ACCORDANCE WITH THE PRODUCT RELEASE GUIDELINES, AND THAT NO NONCONFORMANCES OR PROCESS DEVIATIONS WERE OBSERVED. ADDITIONALLY, THE TISSUE BANK (ALLOSOURCE) CONDUCTED AN IN-DEPTH REVIEW OF THE DONOR RECORDS ASSOCIATED WITH THIS LOT. THE REVIEW SHOWED THE PROCUREMENT CULTURES AND SEROLOGY RESULTS WERE IN ACCORDANCE WITH (B)(6) GUIDELINES. TEST RESULTS FROM A SAMPLE OF THE PT'S SPINAL FLUID COINCIDE WITH THE PRESUMPTIVE DIAGNOSIS: CREUTZFELDT-JAKOB DISEASE (CJD). THE ATTENDING PHYSICIAN ALSO STATED SHE IS DISMISSING ANY CONCERNS WITH THE DYNABLAST PRODUCT, AND HAS ELIMINATED DYNABLAST AS A POTENTIAL CONTRIBUTING FACTOR TO THE PT'S DETERIORATING HEALTH. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) RECEIVED A CALL FROM A WOMAN WHO IDENTIFIED HERSELF AS THE DAUGHTER OF A PT WHO HAD BECOME EXTREMELY ILL WEEKS AFTER RECEIVED A DYNABLAST BONE GRAFT. THE CALLER REPORTED THAT HER FATHER WAS HOSPITALIZED AT (B)(6). SINCE THE BONE GRAFT SURGERY ON (B)(6) 2011, HER FATHER HAD LOST FUNCTION OF HIS ARM, LEG, AND BRAIN. THE CALLER REQUESTED WE CONDUCT A REVIEW OF THE DYNABLAST LOT USED IN HER FATHER'S PROCEDURE TO ATTEMPT TO ELIMINATE THE DYNABLAST AS A POSSIBLE SOURCE OF HER FATHER'S DETERIORATING HEALTH. AS REPORTED BY THE PT'S DENTAL CLINICIAN, THE PT RECEIVED A DYNABLAST GRAFT FOLLOWING IMMEDIATE EXTRACTION AT (FDI DENTAL SITE 15). THE SITE WAS COVERED WITH AN ETHICON PATCH, AND THE ENTIRE PROCEDURE WAS UNEVENTFUL. THE PT HAS ALSO TRAVELLED TO AND SPENT 3 WEEKS IN FRANCE AFTER THE PROCEDURE. THE PRESUMPTIVE DIAGNOSIS AS INDICATED BY THE ATTENDING PHYSICIAN AT (B)(6) IS CREUTZFELDT-JAKOB DISEASE (CJD); A CONCLUSIVE DIAGNOSIS IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNABLAST PUTTY 5CC NUN KEYSTONE DENTAL 10.220.1050 101109

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R| S PREDNISONE| CALCIUM| AZATHIOPRINE