BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXIMUS OS IMPLANT

    MDR report key: 751347 · Received August 9, 2006

    Report

    Report Number
    1060818-2006-00001
    Event Type
    Other
    Date Received
    August 9, 2006
    Date of Event
    December 8, 2005
    Report Date
    August 9, 2006
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K041938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN (CUSTOMER) DID NOT READ THE INSTRUCTIONS ACCOMPANYING THE MAXIMUS OS IMPLANT AND THE IMPLANT PROCEDURE MANUAL PRIOR TO PREPPING THE PATIENT. THE CUSTOMER SAID THAT WHEN PATIENT WAS PREPPED, HE DISCOVERED THAT HE HAD NO INSTRUMENTS TO PLACE THE IMPLANTS. THE CUSTOMER CLOSED THE OSTEOTOMIES, AND SUBSEQUENTLY PLACED AND RESTORED THE IMPLANTS AFTER HE GOT THE RIGHT INSTRUMENTS. INSTRUCTIONS FOR USE, L0109 REVISION 2005, WHICH THE CUSTOMER HAD RECEIVED, CLEARLY STATED THAT THE IMPLANT PROCEDURE MANUAL SHOULD BE REVIEWED PRIOR TO ATTEMPTING PLACEMENT, THE DRIVER INSTRUMENTS REQUIRED FOR MAXIMUS OS IMPLANT ARE DIFFERENT FROM THE DRIVER INSTRUMENTS REQUIRED FOR MAXIMUS 3.0 IMPLANT PLACEMENT, AND IT MUST BE VERIFIED BY THE CLINICIAN THAT THE PROPER INSTRUMENTS ARE AT HAND AND AVAILABLE PRIOR TO ATTEMPTING PLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER SAID THAT WHEN PATIENT WAS PREPPED, HE DISCOVERED THAT HE DID NOT HAVE PROPER INSTRUMENTS TO PLACE THE IMPLANTS. THE CUSTOMER CLOSED THE OSTEOTOMIES, AND SUBSEQUENTLY PLACED AND RESTORED THE IMPLANTS AFTER HE GO THE RIGHT INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMUS OS IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE BIOHORIZONS IMPLANT SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other