BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0003 - 4060-2 KIT

    MDR report key: 1340798 · Received January 21, 2009

    Report

    Report Number
    2023141-2009-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2009
    Date of Event
    July 1, 2008
    Report Date
    January 21, 2009
    Manufacturer
    ZIMMER DENTAL INC.
    Product Code
    LYC
    PMA / PMN Number
    K811101
    Removal / Correction Number
    2023141-01/19/2009-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: COMPLAINT CAN NOT BE VERIFIED. VISUAL INSPECTION FOUND THAT VIALS WERE RETURNED IN A PLASTIC BAG EMPTY. NO CHIPS WERE FOUND ON RETURNED VIALS. GLASS CHIP WAS RETURNED IN A SEPARATE PLASTIC BAG. LOT TRACING WAS COMPLETED AND WAS FOUND ACCEPTABLE TO RELEASE CRITERIA. THE LOT LISTED AND TWO OTHERS WILL BE THE SUBJECT OF A REMOVAL ACTION REPORTED TO THE DISTRICT OFFICE BY ZIMMER CORPORATE STAFF. THIS 3500A FORM IS BEING FILED MORE THAN 30 DAYS AFTER THE RECEIPT OF THE COMPLAINT INFORMATION. NO INJURY WAS INVOLVED IN THE COMPLAINT REPORTED. UPON COMPLETION OF OUR INVESTIGATION, IT WAS DETERMINED THAT A REMOVAL ACTION WOULD BE UNDERTAKEN AND REPORTED TO THE FDA. THIS MDR IS BEING FILED IN CONJUNCTION WITH THAT REPORTABLE REMOVAL ACTION.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT A FRAGMENT OF THE GLASS VIAL WAS MIXED IN THE CALCITITE. NO PATIENT INVOLVEMENT OR IMPACT WAS REPORTED. THE DISTRIBUTOR DID NOT PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0003 - 4060-2 KIT PARTICLES, CALCITITE LYC ZIMMER DENTAL INC. NA 60864773

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK