BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNAGRAFT-D GEL 5CC

    MDR report key: 2474232 · Received February 28, 2012

    Report

    Report Number
    3005990499-2012-00003
    Event Type
    Other
    Date Received
    February 28, 2012
    Report Date
    February 6, 2012
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF KEYSTONE DENTAL AND INTEGRA LIFESCIENCES COMPLAINT DATABASES REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. KEYSTONE DENTAL AND INTEGRA LIFESCIENCES CONDUCTED A REVIEW OF THE BATCH RECORDS FOR DYNABLAST LOT 110762 WHICH INDICATED THIS PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT'S ACCEPTANCE AND RELEASE CRITERIA, AND THAT NO NONCONFORMANCE OR DEVIATIONS WERE OBSERVED. KEYSTONE DENTAL'S INVESTIGATION REVEALED THIS CLINICIAN USED A 5CC DYNABLAST GEL BEYOND IT'S LABELED SPECIFICATIONS. THIS CLINICIAN REPORTED THAT HE USED A SINGLE 5CC DYNABLAST GEL ON AT LEAST 15 PATIENTS. THE CLINICIAN DID NOT SAVE THE PRODUCT THAT WAS RETRIEVED FROM ANY OF THE PATIENTS. THIS CLINICIAN WAS REMINDED THAT THIS PRODUCT WAS INDICATED FOR SINGLE USE DURING A CLINICAL FOLLOW-UP CALL. KEYSTONE DENTAL CONTACTED THE CLINICIAN 5 TIMES (3 PHONE CALLS AND 2 E-MAILS) AND REQUESTED DETAILS FOR EACH PATIENT RECEIVING THE DYNAGRAFT GEL. DESPITE REPEATED ATTEMPTS KEYSTONE DENTAL HAS BEEN UNABLE TO OBTAIN THE DETAILS REQUIRED TO COMPLETE PATIENT SPECIFIC MEDWATCH REPORTS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2012, KEYSTONE DENTAL'S (B)(4) RECEIVED A CALL FROM A CLINICIAN WHO REPORTED THAT THE DYNAGRAFT GEL TURNED BLACK AND CRUMBLY. THE CLINICIAN REPORTED THAT HE USE A SINGLE 5CC DYNABLAST GEL ON AT LEASE 15 PATIENTS, BONE AND TISSUE REGRESSION WAS EVIDENT IN MOST OF THESE CASES. THE CLINICIAN DID NOT PROVIDE PROCEDURE DATES OR PATIENT SPECIFIC DETAILS DURING THIS CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAGRAFT-D GEL 5CC NUN KEYSTONE DENTAL 10-110-1070 110762

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other