BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLIF ALLOGRAFT INSERTER

    MDR report key: 4093464 · Received September 16, 2014

    Report

    Report Number
    0002242816-2014-00070
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 16, 2014
    Report Date
    November 18, 2014
    Manufacturer
    EBI, LLC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. PER THE PRODUCT EVALUATION REPORT, THE ENGINEER REVIEWED THE MANUFACTURING RECORDS AND INDICATED THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE ENGINEER DETERMINED THAT THE LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO THE PRONGS EXPERIENCING A LOAD THAT EXCEEDED THE MECHANICAL STRENGTH OF THE FEATURE.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE DEVICE EVALUATION IS IN PROCESS, CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A TINE BROKE OFF THE INSERTER DURING SURGERY, THE TINE IS STUCK IN THE INTERVERTEBRAL SPACE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571389 PLIF ALLOGRAFT INSERTER PLIF ALLOGRAFT INSERTER HXX EBI, LLC. N/A 14142

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability