BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C IMPLANT, UNKNOWN SIZE

    MDR report key: 12360468 · Received August 24, 2021

    Report

    Report Number
    3004788213-2021-00089
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    August 3, 2021
    Report Date
    December 14, 2021
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED, NO PHOTOS WERE PROVIDED. DEVICE EVALUATION UNABLE TO BE COMPLETED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE REVISION COULD BE DUE TO UNKNOWN SURGICAL, PATIENT OR EVENT FACTORS. DHR REVIEW LOT NUMBER IS NOT KNOWN, SO DHR REVIEW COULD NOT BE PERFORMED. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED A REVISION WAS PERFORMED ON AN ROI-C CONSTRUCT BECAUSE THE PATIENT'S SYMPTOMS RETURNED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: ROI-C TITANIUM-COATED IMPLANT SYSTEM OR LDR SPINE CERVICAL INTERBODY FUSION SYSTEM. PRODUCT CODE: OVE OR ODP. CATALOG NUMBER: CMC14XXP, MC13XXP, OR MC14XXP. 510K NUMBER: K151934 OR K091088. 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. REFERENCE REPORT 3004788213-2021-00088.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED ON AN ROI-C CONSTRUCT BECAUSE THE PATIENT'S SYMPTOMS RETURNED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258211 ROI-C IMPLANT, UNKNOWN SIZE SEE H10 OVE LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R