BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE

    MDR report key: 2981351 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-01211
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    July 25, 2011
    Manufacturer
    SYNTHES
    Product Code
    LYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: IMPLANT DATE IS UNKNOWN. THIS REPORT IS FOR 1 UNKNOWN SPINE PRODUCT.

    Description of Event or Problem · 1

    PATIENT 4, IT WAS REPORTED THAT THE SPACER HAS MOVED. THIS IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME BACK PAIN AT L5-S1 AS WELL AS PAIN IN THE RIGHT LEG. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84493 SPINE LYQ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention