BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM

    MDR report key: 2651951 · Received July 9, 2012

    Report

    Report Number
    9617544-2012-00285
    Event Type
    Other
    Date Received
    July 9, 2012
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K061813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: THE IMPLICATED DEVICE WAS NOT AVAILABLE FOR EVAL AND THE CORRESPONDING LOT INFO SUPPLIED IS UNK. COMPLAINT HISTORY ANALYSIS: NO PREVIOUS RECORDS FOR ON THE MANTIS PRODUCT RANG. IT IS NOTED THAT IMPLANTS ARE MADE OF TITANIUM ALLOY WHICH IS A BIOCOMPATIBLE RAW MATERIAL. RISK ASSESSMENT: THIS SECTION WAS NOT COMPLETED AS THE REPORTED UNEXPECTED FAILURE COULD NOT BE CONFIRMED OR INVESTIGATED. CONCLUSION: A THOROUGH INVESTIGATION CANNOT BE PERFORMED DUE TO A LACK OF ESSENTIAL ELEMENTS AND INFO. THE REPORTED FAILURE CANNOT BE CONFIRMED OR INVESTIGATED BASED ON THE MINIMAL INFO RECEIVED TO DATE. THE SQUEAKING NOISE COULD SIGNIFY THAT THERE IS COMPONENT MOVEMENT CAUSED BY BLOCKER UNDER/OVER TIGHTENING OR EVENT NON-FUSION. THIS IS THE 1ST COMPLAINT OF THIS NATURE TO HAVE BEEN RECEIVED ON THE MANTIS PRODUCT RANGE.

    Description of Event or Problem · 1

    PER RAISED WITH MINIMAL INFO. THE SURGEON, MR. (B)(6), REPORTED VIA THE SALES REP, (B)(4), THAT A MALE PT HAD A TWO LEVEL ALIF WITH MANTIS PERC SCREWS APPROX 12 MONTHS AGO. THE SURGEON REPORTED THAT SIX MONTHS POST-OPERATIVELY, THE DEVICES BEGAN SQUEAKING WHICH WAS AUDIBLE FROM THE OTHER SIDE OF THE ROOM. THE SURGEON EXPLAINED THAT IT IS AS THOUGH THE PT IS STEPPING ON A LOOSE FLOOR BOARD, ALTHOUGH, THE PT HAS REPORTED NO PAIN. THE SURGEON HAS SPECIFICALLY REQUESTED FURTHER DETAILS FROM STRYKER, INCLUDING WHETHER SIMILAR EVENTS HAVE BEEN REPORTED PREVIOUSLY, WHETHER WE EXPECT THAT IT WOULD RESOLVE AS IT WEARS SMOOTH AND WHETHER IT IS WORTHY EXPLORING AND...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM IMPLANT MNH STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK