BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

    MDR report key: 15240078 · Received August 17, 2022

    Report

    Report Number
    3004788213-2022-00062
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    June 29, 2022
    Report Date
    January 17, 2023
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVE
    UDI-DI
    03662663017305
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED IN THE US, BUT IS SIMILAR TO MC1322, WHICH CLEARED IN THE US UNDER K151934. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REFERENCE REPORT (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICES WERE RETURNED IN A CONTAMINATED STATE SO ONLY A VISUAL INSPECTION WAS ABLE TO BE PERFORMED. THE ARMS OF THE PLATE APPEAR TO BE BENT INWARDS AND THE CAGE WAS CRACKED AROUND THE PLATE POINT OF ENTRY. POTENTIAL ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO EXCESS FORCE APPLIED DURING REMOVAL. DHR REVIEW: THE DHRS WERE REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICES WERE LIKELY CONFORMING WHEN THEY LEFT ZIMVIE¿S CONTROL. DEVICE USAGE: 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 THAT A WAREHOUSE FOUND AN ROI-C CAGE THAT IS FRACTURED AND A PLATE THAT HAS A BENT ARM DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. FOLLOW-UP WITH THE DISTRIBUTOR DETERMINED THE ANCHORS WERE TOO SMALL FOR THE PATIENT'S VERTEBRAL BODY. THE CAGE AND ANCHORS WERE REMOVED AND REPLACED WITH ANOTHER LARGER SIZE. SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WAREHOUSE FOUND AN ROI-C CAGE THAT IS FRACTURED AND A PLATE THAT HAS A BENT ARM DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. FOLLOW-UP WITH THE DISTRIBUTOR DETERMINED THE ANCHORS WERE TOO SMALL FOR THE PATIENT'S VERTEBRAL BODY. THE CAGE AND ANCHORS WERE REMOVED AND REPLACED WITH ANOTHER LARGER SIZE. SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238109 ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM ROI-C TITANIUM-COATED IMPLANT SYSTEM OVE LDR MÉDICAL NA L20031 03662663017305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown