BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAHARA ¿ STABILIZATION SYSTEM

    MDR report key: 8949099 · Received August 30, 2019

    Report

    Report Number
    3004774118-2019-01075
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    November 8, 2017
    Report Date
    August 30, 2019
    Manufacturer
    STRYKER-SPINE
    Product Code
    OVD
    UDI-DI
    01088857213272
    PMA / PMN Number
    K151481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER COMPLETED ITS ACQUISITION OF K2M, INC. (K2M) ON (B)(6) 2018. AS PART OF INTEGRATION ACTIVITIES STRYKER SPINE PERFORMED A RETROSPECTIVE REVIEW OF K2M POST MARKET SURVEILLANCE COMPLAINTS OR THE PERIOD 2017 TO 2018. THE PURPOSE OF THIS REVIEW WAS TO ASSESS REPORTABILITY DECISIONS AND ENSURE CONSISTENCY WITH THE STRYKER CORPORATE PROCEDURES AND POLICIES. AS A RESULT OF THAT THIS MDR IS BEING FILED. DIMENSIONAL AND MATERIAL ANALYSIS: THE DEVICE REMAINS IMPLANTED; PHYSICAL EVALUATION COULD NOT BE PERFORMED. THE RESPECTIVE MANUFACTURING AND INSPECTION LOT RECORDS WERE REVIEWED WITH ALL ACCEPTED PARTS BEING REPORTED TO SPECIFICATION. A REVIEW OF THE PER SURVEILLANCE REPORT DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. PATIENT PRESENTED A VERY TIGHT DISC SPACE. UPON ADJUSTING THE DEVICE HEIGHT, ATTEMPT WAS MADE TO REACH THE 2ND ADJUSTMENT LEVEL. IT COULD NOT BE CONFIRMED THAT THE SECOND ADJUSTMENT LEVEL WAS FULLY ACHIEVED (ENGAGED). FOLLOW-UP SUGGESTED THE IMPLANT WAS AT THE 1ST ADJUSTMENT. ADJUSTMENT TO THE 2ND LEVEL COULD NOT BE CONFIRMED THEREFORE PRODUCT COLLAPSE FAILURE COULD NOT BE CONCLUDED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED SUBSIDENCE OF APPROXIMATELY 1MM OF A SAHARA AL EXPANDABLE CAGE TWO OR THREE WEEKS POST-OPERATIVELY. THE DEVICE REMAIMS IMPLANTED AND NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743837 SAHARA ¿ STABILIZATION SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION OVD STRYKER-SPINE DWLF 01088857213272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other