BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C ANCHORING PLATE, UNKNOWN SIZE

    MDR report key: 16102319 · Received January 5, 2023

    Report

    Report Number
    3004788213-2023-00002
    Event Type
    Injury
    Date Received
    January 5, 2023
    Report Date
    June 12, 2023
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    PMA / PMN Number
    K151934
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: COMPLAINT UNABLE TO BE CONFIRMED WITH THE PROVIDED IMAGING AND IS UNREFUTED FOR POST-OP AVN (AVASCULAR NECROSIS) AT LEVELS C5-C7. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT, OPERATIVE OR TRAUMATIC FACTORS. DHR REVIEW: DHR REVIEW UNABLE TO BE COMPLETED AS LOT INFORMATION IS NOT KNOWN. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON ONE-YEAR POST-OP IMAGING, IT APPEARS THAT A ROI-C PATIENT PRESENTED WITH AVN (AVASCULAR NECROSIS) AT LEVELS C5-C7 AND THE SURGEON THEORIZES THE PLATES MAY DISRUPT THE VERTEBRAL BODY BLOOD SUPPLY. A REVISION SURGERY WAS PERFORMED TO ADD A POSTERIOR CONSTRUCT AND PERFORM A FORAMINAL DECOMPRESSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON ONE-YEAR POST-OP IMAGING, IT APPEARS THAT A ROI-C PATIENT PRESENTED WITH AVN (AVASCULAR NECROSIS) AT LEVELS C5-C7 AND THE SURGEON THEORIZES THE PLATES MAY DISRUPT THE VERTEBRAL BODY BLOOD SUPPLY. A REVISION SURGERY WAS PERFORMED TO ADD A POSTERIOR CONSTRUCT AND PERFORM A FORAMINAL DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645445 ROI-C ANCHORING PLATE, UNKNOWN SIZE ROI-C TITANIUM-COATED IMPLANT SYSTEM OVE LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R