BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ PREBENT ROD CP TI 40 MM

    MDR report key: 6126430 · Received November 23, 2016

    Report

    Report Number
    3004485144-2016-00328
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    May 15, 2017
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. PATIENT REQUESTED TO KEEP HARDWARE.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO REMOVE AN IMPLANTED ROD THAT WAS CAUSING THE PATIENT PAIN. NO ISSUES WERE FOUND WITH THE ROD. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EVENTS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775424 SEQ PREBENT ROD CP TI 40 MM ROD NKB ZIMMER BIOMET SPINE N/A 82LB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other