BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10958

    MDR report key: 2994064 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-10958
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    July 11, 2004
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS REC'D FOR EVAL AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PARTICIPATED IN A PROSPECTIVE UNCONTROLLED STUDY OF THE SYNEX DEVICE FOR RESTORING VERTEBRAL HEIGHT FOLLOWING CORPECTOMY/VERTEBRECTOMY OF ANY SINGLE LEVEL FROM T1 TO L5. PT WAS IMPLANTED WITH A SYNEX CAGE AND AN ANTERIOR THORACOLUMBAR LOCKING PLATE (ATLP) FOR SUPPLEMENTAL FIXATION. POSTOPERATIVELY, THE PT EXPERIENCED INFECTION/SEPSIS, REQUIRING ANTIBIOTICS TO CLEAR A URINARY TRACT INFECTION. THIS IS REPORT 6 OF 8 FOR THIS EVENT. THIS REPORT IS ON THE SCREW 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84145 MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention