BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELREPLACE TAPERED GROOVY NP 3.5X16MM

    MDR report key: 2714811 · Received March 23, 2011

    Report

    Report Number
    2027763-2011-50079
    Event Type
    Death
    Date Received
    March 23, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 22, 2011
    Manufacturer
    NOBEL BIOCARE USA LLC
    Product Code
    DZE
    PMA / PMN Number
    K050258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL BRAND NAME, CATALOG, LOT NUMBERS: BRAND NAME: NOBELREPLACE TAPERED GROOVY WP 5X10MM, CAT #: 32220, LOT#: 446537, EXPIRATION DATE: 10/02/2015, APPROX AGE OF DEVICE: 4 MONTHS; NOBELREPLACE TAPERED GROOVY RP 4.3X13MM, 32217, 447152, 10/12/2015, 4 MONTHS; NOBELREPLACE TAPERED GROOVY RP 4.3X16MM, 32218, 724424, 03/14/2015, 10 MONTHS; NOBELREPLACE TAPERED GROOVY WP 5X13MM, 32221, 732517, 09/23/2015, 4 MONTHS; NOBELREPLACE TAPERED GROOVY RP 4.3X16MM, 32218, 732902, 09/26/2015, 4 MONTHS; NOBELREPLACE TAPERED GROOVY RP 4.3X13MM, 32217, 739678, 01/16/2016, 1 MONTH; NOBELREPLACE TAPERED GROOVY WP 5X13MM, 32221, 739770, 01/23/2016, 1 MONTH.

    Description of Event or Problem · 1

    A SUMMARY OF THE MEDICAL INFO PROVIDED SHOWS THAT A (B)(6) MALE WITH PREVIOUS HISTORY OF CARDIAC ARRHYTHMIA, RESPIRATORY COMPROMISE REQUIRING OXYGEN, WITH CURRENT OBESITY AND TOBACCO USE (CHEWING) WAS BEING TREATED WITH 17 DENTAL IMPLANTS PERFORMED WITH LOCAL ANESTHESIA AND SEDATION. FURTHER MEDICAL HISTORY INCLUDING PRESCRIPTION MEDICATION IS NOT CURRENTLY AVAILABLE. AT THE END OF THE APPOINTMENT, THE PT BECAME NON-RESPONSIVE TO VERBAL STIMULI, WAS RESUSCITATED IN THE OFFICE, TAKEN BY AMBULANCE, ADMITTED TO AN INTENSIVE CARE UNIT AND SUBSEQUENTLY DIED. NO AUTOPSY WAS PERFORMED. THE ATTENDING PHYSICIAN AT THE INTENSIVE CARE UNIT OBSERVED EVIDENCE OF A BLOOD CLOT FROM THE LEG. EXAMINATION OF A DETAILED MEDICAL HISTORY INCLUDING MEDICATIONS AND OPERATIVE REPORT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOBELREPLACE TAPERED GROOVY NP 3.5X16MM NONE DZE NOBEL BIOCARE USA LLC 436495

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death