BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS REDUX BLOCKER

    MDR report key: 5788259 · Received July 12, 2016

    Report

    Report Number
    0009617544-2016-00283
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    January 1, 2016
    Report Date
    June 17, 2016
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    UDI-DI
    04546540671431
    PMA / PMN Number
    K092631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: NO LOT # WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. THE STRYKER REP REPORTED THAT 12NM WAS ACHIEVED DURING FINAL TIGHTENING, THE PATIENT DID NOT FALL AND PATIENT HEALTH, LIFESTYLE AND BONE QUALITY WAS UNKNOWN. CONCLUSION: A PLAUSIBLE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, AS THE PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMARY SURGERY FOR L3 BURST FRACTURE (L3/4 PLIF AND L1-5 PIF) WAS PERFORMED ON (B)(6) 2015. ONE WEEK AFTER SURGERY, THE L1 BLOCKER BACKOUT WAS FOUND. THE OBSERVATION IS BEING CARRIED OUT. A REVISION SURGERY IS NOT PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMARY SURGERY FOR L3 BURST FRACTURE (L3/4 PLIF AND L1-5 PIF) WAS PERFORMED ON (B)(6) 2015. ONE WEEK AFTER SURGERY, THE L1 BLOCKER BACKOUT WAS FOUND. THE OBSERVATION IS BEING CARRIED OUT. A REVISION SURGERY IS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440834 MANTIS REDUX BLOCKER PEDICLE SCREW SPINAL SYSTEM. MNH STRYKER SPINE-FRANCE UNKNOWN 04546540671431

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR