BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMID® ANTERIOR PLATE FIXATION SYSTEM

    MDR report key: 3943715 · Received July 18, 2014

    Report

    Report Number
    1030489-2014-03258
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED/ADDITIONAL INFORMATION: DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 9873135 / LOT: 0290155W (3-HOLE 35MM PLATE) MFG DATE: 2013-11-12.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 8969121/ LOT: UNKNOWN, UNKNOWN VARIABLE ANGLE SCREW (X3). ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR LUMBAR SPINAL FUSION USING A LUMBAR PLATE SYSTEM. DURING A POST-OPERATIVE VISIT APPROXIMATELY 3 WEEKS AFTER SURGERY, X-RAYS WERE TAKEN AND SHOWED THAT THE TOP OF THE PLATE HAD PULLED OUT. THE PATIENT HAD A CAT SCAN WITH CONTRAST WHICH REVEALED ONE OF PATIENT'S LARGE VEINS WAS CLOSE ENOUGH TO THE CONSTRUCT TO CAUSE CONCERN. A REVISION SURGERY WAS PERFORMED TO REMOVE THE ANTERIOR PLATE AND IMPLANT POSTERIOR HARDWARE TO SECURE THE FUSION INSTEAD. DURING THE REVISION, IT WAS FOUND THAT ALL THREE OF THE SCREWS IN THE PLATE WERE LOOSE PRIOR TO BEING REMOVED. PATIENT ALLEGES THAT BY UNDERGOING THE REVISION SURGERY, THE RECOVERY WAS "GRUELLING" AND MUCH MORE PAINFUL BY FAR THAN THE LAST. THE PATIENT ALSO REPORTS SUFFERING FROM RETROGRADE EJACULATION WHICH DID NOT OCCUR AFTER THE FIRST PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421300 PYRAMID® ANTERIOR PLATE FIXATION SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 35MM LOCKING PLATE,SET SCREW,VA SCREWS