BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EVEREST MI SCREW

    MDR report key: 12627454 · Received October 13, 2021

    Report

    Report Number
    3004774118-2021-00313
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    January 1, 2018
    Report Date
    January 26, 2022
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'ONE CENTER¿S EXPERIENCE WITH HYBRID TECHNIQUE FOR LUMBAR SPINE INSTRUMENTATED SURGERIES: EVALUATION OF DIFFERENT INSTRUMENTATION SYSTEMS AND THEIR MANAGEMENT' IN THE JOURNAL OF WORLD NEUROSURGERY, VOLUME 120 (153-158) 2018, WAS REVIEWED. VISUAL, FUNCTIONAL, DIMENSIONAL, AND MATERIAL ANALYSIS INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT AVAILABLE. DEVICE AND COMPLAINT HISTORY RECORDS WERE NOT REVIEWED AS A VALID LOT NUMBER WAS NOT PROVIDED AND COULD NOT BE OBTAINED. THE PURPOSE OF THE STUDY WAS TO IDENTIFY THE MOST USEFUL AND COMFORTABLE INSTRUMENTATION EXPERIENCE TO PERFORM THE HYBRID TECHNIQUE (A MIDLINE SKIN INCISION FOLLOWED BY SCREW PLACEMENT THROUGH THE FASCIA, FOLLOWED BY DECOMPRESSION VIA MINI MEDIAN INCISION, AND THEN FOLLOWED BY INTERBODY PLACEMENT BETWEEN SUBSEQUENT SCREWS). 16 PATIENTS WERE INCLUDED IN THIS STUDY. THE PATIENTS WERE DIVIDED INTO FOUR GROUPS: GROUP A, GROUP B, GROUP C, GROUP D. PATIENTS IN GROUP C WERE IMPLANTED WITH EVEREST SCREWS AND USED THE SERENGETI RETRACTOR SYSTEM. IT WAS REPORTED THAT IN GROUP C, THE 'PLASTIC TAIL' OF ONE EVEREST SCREW BROKE DURING SCREW POSITIONING INTRA-OPERATIVELY. THIS EVENT RESULTED IN DISCOMFORT DURING SUBSEQUENT SYSTEM CLOSURE. NO ADVERSE CONSEQUENCES WERE REPORTED. AS THE DEVICE WAS NOT RETURNED AND ADDITIONAL INFORMATION WAS NOT AVAILABLE, A CAUSE CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 0

    THIS RECORD CAPTURES A REVIEW OF "ONE CENTER¿S EXPERIENCE WITH HYBRID TECHNIQUE FOR LUMBAR SPINE INSTRUMENTATED SURGERIES: EVALUATION OF DIFFERENT INSTRUMENTATION SYSTEMS AND THEIR MANAGEMENT" FROM THE JOURNAL OF WORLD NEUROSURGERY (WORLD NEUROSURG. (2018) 120:153-158.HTTPS://DOI.ORG/10.1016/J.WNEU.2018.08.204). THE AIM OF THE STUDY WAS TO INVESTIGATE THE BEST SYSTEM TO PERFORM A HYBRID TECHNIQUE IN LUMBAR SPINE FUSION PROCEDURES. SIXTEEN CONSECUTIVE PATIENTS SCHEDULED FOR ELECTIVE INSTRUMENTATED SINGLE SEGMENT LUMBAR SURGERY WERE ENROLLED IN THE STUDY. IN KEEPING WITH THE AIM OF THIS INVESTIGATION, PATIENTS WERE RANDOMLY ASSIGNED TO 1 OF 4 GROUPS: A, B, C, OR D. GROUP C USED STRYKER SPINE EVEREST, SERENGETI, AND TERRA NOVA DEVICES, WHILE THE OTHER GROUPS USED OTHER NON STRYKER SPINE DEVICES. IT WAS REPORTED THAT DURING SCREW POSITIONING, THE TAB OF AN EVEREST MI SCREW BROKE. THIS RESULTED IN SURGEON DISCOMFORT DURING SUBSEQUENT SYSTEM CLOSURE. HOWEVER, ALL THE FRACTURED PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    THE ARTICLE 'ONE CENTER¿S EXPERIENCE WITH HYBRID TECHNIQUE FOR LUMBAR SPINE INSTRUMENTATED SURGERIES: EVALUATION OF DIFFERENT INSTRUMENTATION SYSTEMS AND THEIR MANAGEMENT' IN THE JOURNAL OF WORLD NEUROSURGERY, VOLUME 120 (153-158) 2018, WAS REVIEWED. DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 1

    THIS RECORD CAPTURES A REVIEW OF "ONE CENTER¿S EXPERIENCE WITH HYBRID TECHNIQUE FOR LUMBAR SPINE INSTRUMENTATED SURGERIES: EVALUATION OF DIFFERENT INSTRUMENTATION SYSTEMS AND THEIR MANAGEMENT" FROM THE JOURNAL OF WORLD NEUROSURGERY (WORLD NEUROSURG. (2018) 120:153-158.HTTPS://DOI.ORG/10.1016/J.WNEU.2018.08.204). THE AIM OF THE STUDY WAS TO INVESTIGATE THE BEST SYSTEM TO PERFORM A HYBRID TECHNIQUE IN LUMBAR SPINE FUSION PROCEDURES. SIXTEEN CONSECUTIVE PATIENTS SCHEDULED FOR ELECTIVE INSTRUMENTATED SINGLE SEGMENT LUMBAR SURGERY WERE ENROLLED IN THE STUDY. IN KEEPING WITH THE AIM OF THIS INVESTIGATION, PATIENTS WERE RANDOMLY ASSIGNED TO 1 OF 4 GROUPS: A, B, C, OR D. GROUP C USED STRYKER SPINE EVEREST, SERENGETI, AND TERRA NOVA DEVICES, WHILE THE OTHER GROUPS USED OTHER NON STRYKER SPINE DEVICES. IT WAS REPORTED THAT DURING SCREW POSITIONING, THE TAB OF AN EVEREST MI SCREW BROKE. THIS RESULTED IN SURGEON DISCOMFORT DURING SUBSEQUENT SYSTEM CLOSURE. HOWEVER, ALL THE FRACTURED PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524426 UNKNOWN EVEREST MI SCREW POSTERIOR CERVICAL SCREW SYSTEM NKB K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown