BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACER, UNKNOWN SIZE

    MDR report key: 8926274 · Received August 23, 2019

    Report

    Report Number
    3004788213-2019-00277
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    August 5, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: RESULTS AND CONCLUSIONS. THE DEVICE WAS NOT RETURNED, THE LOT NUMBER IS UNKNOWN, AND NO X-RAYS OR PHOTOS WERE PROVIDED SO AN EVALUATION WAS UNABLE TO BE PERFORMED. THEREFORE, THERE ARE NO FINDINGS AVAILABLE AND THE CAUSE CANNOT BE ESTABLISHED. THE DEVICE'S LABELING IDENTIFIES NON-UNION AS A POTENTIAL RISK OF USING THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PSEUDOARTHROSIS WAS FOUND AT C4/5 APPROXIMATELY 30 MONTHS POST-OPERATIVE. THERE WERE NO SPECIFIC DEVICE MALFUNCTIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PSEUDOARTHROSIS WAS FOUND AT C4/5 APPROXIMATELY 30 MONTHS POST-OPERATIVE. THERE WERE NO SPECIFIC DEVICE MALFUNCTIONS REPORTED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM OR ROI-C TITANIUM-COATED IMPLANT SYSTEM. PRODUCT CODE: ODP OR OVE. 510K: K091088 OR K151934. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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

    IT WAS REPORTED THAT A PSEUDOARTHROSIS WAS FOUND AT C4/5 APPROXIMATELY 30 MONTHS POST-OPERATIVE. THERE WERE NO SPECIFIC DEVICE MALFUNCTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718649 SPACER, UNKNOWN SIZE SEE H10 ODP LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other