BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW HEAD POLYAX F/MATRIX 5.5 TAN

    MDR report key: 3568318 · Received January 10, 2014

    Report

    Report Number
    2520274-2014-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SYNTHES USA BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE: MNH, MNI, KWO, KWP. US LOT NUMBER 7356429 REPORTED FOR THIS DEVICE; EXPIRATION DATE 04/09/2033; MANUFACTURE DATE 04/09/2013. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PART NUMBER 04.632.001, LOT #7356429 DHRS WERE REVIEWED FOR THIS COMPLAINT. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A ROD DURING A LUMBAR SPINAL CANAL STENOSIS CASE, LOCKING CAPS WERE INSERTED INTO THE SCREW HEADS WITH A STRAIGHT FIXING TYPE DRIVER. FOR THE FINAL FIXATION, TWO SCREWS AT THE CAUDAL PART WERE FIXED USING A TORQUE DRIVER AND A COUNTER TORQUE. THE SURGEON TRIED TO TAKE THE SAME PROCEDURE FOR 2 SCREWS AT THE CRANIAD PART, BUT DISCOVERED THERE WAS NO SPACE FOR THE TIP OF THE COUNTER TORQUE ON THEM. THE LOCKING CAP WAS FIXED USING THE TORQUE DRIVER BY GRASPING THE ROD WITH A ROD HOLDER. AT THAT TIME, THE TORQUE LIMITATION OF THE TORQUE DRIVER DID NOT WORK AND THE SET SCREW DID NOT STOP SPINNING AROUND. THE SURGEONS CONFIRMED THE DILATION OF THE POLYAXIAL HEAD AND CROSS THREADING OF THE LOCKING CAPS. AFTER THE REMOVAL OF ALL THE BROKEN ARTICLES, THE SURGEON TOOK A FIXATION PROCEDURE USING A NEW IMPLANT AND THE COUNTER TORQUE, AND COMPLETED THE IMPLANTATION. THIS IS REPORT 2 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19908 SCREW HEAD POLYAX F/MATRIX 5.5 TAN NKB SYNTHES USA BRANDYWINE 8454435

    Patients

    Seq Age Sex Outcome Treatment
    1