BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 15MM

    MDR report key: 4181554 · Received October 17, 2014

    Report

    Report Number
    0001038806-2014-00136
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK063341
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATOR¿S VISUAL INSPECTION OF RETURNED COMPONENT, CERTAIN® RATCHET EXTENSION - LONG 4.1. 5.0. 6.0MM (D) (IRE200) AND OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 15MM (INT3215) CONFIRMED THAT THE FRACTURED TIP AND O-RING OF THE RATCHET EXTENSION DID NOT REMAIN STUCK INSIDE OF THE INT3215 AND HAS NOT BEEN RETURNED FOR REVIEW. THE INTERNAL HEX AND COLLAR OF THE INT3215 APPEAR GROSSLY DAMAGED. THE RATCHET EXTENSION WAS CONFIRMED TO BE AN IRE200 AND NOT AN IMRE200 WHEN COMPARED TO DRAWINGS. THE INT3215 IS RECOMMENDED FOR USE WITH THE IMRE200. FURTHER DIMENSIONAL ANALYSIS CANNOT BE PERFORMED DUE TO THE DAMAGE OF THE AS RETURNED PRODUCT. DHR REVIEW HAS CONFIRMED THE FOLLOWING: THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. A REVIEW OF THE PRODUCT¿S COMPLAINT HISTORY IN ETQ DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED, THE CUSTOMER¿S FAILURE TO MATCH THE RATCHET EXTENSION SIZE WITH THE SIZE OF THE IMPLANT AS INDICATED ON THE PRODUCT LABEL IS THE MOST LIKELY CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE RATCHET WRENCH EXTENSION FRACTURED AND STUCK TO THE IMPLANT. A PORTION OF THE RATCHET WENCH EXTENSION COULD NOT BE REMOVED FROM THE IMPLANT. THE IMPLANT WAS REMOVED AND THE SITE WAS PREPARED FOR FUTURE IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661830 OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 15MM DENTAL IMPLANT DZE BIOMET 3I N/A 2014011559

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention