BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 1942668 · Received December 21, 2010

    Report

    Report Number
    3004788213-2010-00004
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 21, 2010
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    PMA / PMN Number
    K091088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: CATALOG# MC1005T, LOT# 268309/12, EXP DATE: 09/01/2015, AND (B)(4).

    Description of Event or Problem · 1

    A REPORT CAME IN FROM A SURGEON ON (B)(6) 2010 STATING THAT THE PEEK CAGE OF AN ROI-C VERTEBRIDGE CONSTRUCT LOOKED LIKE IT "EXPLODED" DURING A POST-OP FOLLOW-UP VISIT AND A REVISION WAS PLANNED. DURING REVIEW OF X-RAYS PROVIDED, IT WAS OBSERVED THAT THE VERTEBRIDGE CONSTRUCT LOOKED TO BE INTACT BUT WAS IMPLANTED TOO FAR LATERALLY. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THIS PLACEMENT LEAD TO A BONE FRAGMENT ANTERIOR TO THE VERTEBRAL BODY WHICH WAS INITIALLY MISTAKEN FOR PEEK BY THE SURGEON. POST-REVISION SURGERY, THE SURGEON AGREED THAT THE ROI-C CONSTRUCT WAS PLACED TOO FAR LATERALLY IN THIS CASE. THE REMOVAL OF THE CONSTRUCT REVEALED THAT THE CONSTRUCT WAS COMPLETELY INTACT (BOTH VERTEBRIDGE ANCHORING PLATES WERE INTACT AND STILL ENGAGED IN THE PEEK CAGE), HOWEVER, THE PEEK CAGE USED IN THIS CASE WAS UNDERSIZED. THE ROI-C CONSTRUCT WAS REPLACED WITH A CORTICAL BONE DOWEL AND A CERVICAL PLATE. AS OF (B)(4) 2010, THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDR SPINE ROI-C INTERBODY FUSION DEVICE INTERBODY FUSION DEVICE ODP LDR MEDICAL ROI-C CONSTRUCT 875212000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other