BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C IMPLANT, UNKNOWN SIZE

    MDR report key: 12505644 · Received September 21, 2021

    Report

    Report Number
    3004788213-2021-00103
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    May 4, 2020
    Report Date
    December 3, 2021
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED, AND PHOTOS WERE NOT PROVIDED, SO DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE IT WAS MENTIONED THAT A NEEDLE WAS USED IN AN ATTEMPT TO REMOVE THE ROI-C DEVICE. DHR REVIEW DHR WAS UNABLE TO BE REVIEWED AS LOT NUMBER IS NOT KNOWN. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT BECAME NAUSEOUS AND DIZZY AFTER A HOME HEALTH CARE NURSE TRIED TO REMOVE AN ROI-C CAGE IMPLANTED 3 DAYS EARLIER USING A NEEDLE. THE NURSE SUBSEQUENTLY HAD TO PERFORM CHEST COMPRESSIONS. AFTER THIS, THE PATIENT STARTED FEELING PAIN, RINGING IN THE EAR, AND MUSCLE SPASMS. X-RAYS THEN SHOWED THE DEVICE HAD SHIFTED TO THE RIGHT. THE PATIENT'S SURGEON SUGGESTED A REVISION SURGERY, THE PATIENT DECLINED BECAUSE THE PROCEDURE SOUNDED TOO DANGEROUS.

    Additional Manufacturer Narrative · 1

    PMA/510K NUMBER: K150765 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 THE PATIENT BECAME NAUSEOUS AND DIZZY AFTER A HOME HEALTH CARE NURSE TRIED TO REMOVE AN ROI-C CAGE IMPLANTED 3 DAYS EARLIER USING A NEEDLE. THE NURSE SUBSEQUENTLY HAD TO PERFORM CHEST COMPRESSIONS. AFTER THIS, THE PATIENT STARTED FEELING PAIN, RINGING IN THE EAR, AND MUSCLE SPASMS. X-RAYS THEN SHOWED THE DEVICE HAD SHIFTED TO THE RIGHT. THE PATIENT'S SURGEON SUGGESTED A REVISION SURGERY, THE PATIENT DECLINED BECAUSE THE PROCEDURE SOUNDED TOO DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406824 ROI-C IMPLANT, UNKNOWN SIZE ROI-C TITANIUM-COATED IMPLANT SYSTEM OVE LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other