BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRS POLYAXIAL SCREW BODY TAN

    MDR report key: 3192552 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04133
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K113044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THE DISCONNECTION OF THE POLYAXIAL HEADS. THE PART WAS MANUFACTURED ACCORDING TO OUR SPECIFICATIONS. NO PRODUCT DEFECT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISCONNECTION OF THE POLYAXIAL HEADS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE MIRS SYSTEM WAS USED TO REPAIR A FRACTURE OF THE 7TH THORACIC VERTEBRAE. FENESTRATED 5MM POLYAXIAL SCREWS WERE PLACED IN THE 5TH AND 6TH THORACIC VERTEBRAE FOR IN SITU CEMENT AUGMENTATION IN A TYPICAL MANNER. AFTER DOCKING, LOCKING OF THE LONGITUDINAL MEMBERS AND SHEARING OF THE SCREW BODIES, THE FINAL X-RAY SHOWS A DISCONNECTION OF THE POLYAXIAL HEADS FROM THE SCREW BODIES, WHICH UNTIL THEN WAS NOT NOTICEABLE. THIS PROBLEM OCCURRED WITH 3 5 MM SCREWS. THERE WERE NO ABNORMALITIES IN THE SURGICAL PROCEDURE. IN CORRECTING THE SITUATION, IT WAS NOTICEABLE THAT THE HEADS OF THE CEMENT-AUGMENTED INTRAPEDICULAR SCREWS THAT REMAINED HAD ALL BEEN FILLED IN BY CEMENT, SO THAT EVEN REMOVAL OF THE SCREWS WOULD HAVE BEEN DIFFICULT (THAT WAS NOT NECESSARY IN THIS CONCRETE CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294378 MIRS POLYAXIAL SCREW BODY TAN NKB SYNTHES GMBH 7948394

    Patients

    Seq Age Sex Outcome Treatment
    1