BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2896001 · Received November 20, 2012

    Report

    Report Number
    2530088-2012-00990
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 22, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION COULD NOT BE COMPLETED BECAUSE THE PRODUCT WAS RECEIVED AS A CONSTRUCT, RAW MATERIAL CANNOT BE MEASURED, BUT WAS VERIFIED AS CORRECT ON DHR. INSTRUMENT FEATURE CANNOT BE MEASURED BECAUSE OF DAMAGE. THE PRODUCT DEVELOPMENT EVENT EVALUATION IS REPORTED AS FOLLOWS: THE DESIGN IS APPROPRIATE FOR THE INTENDED USE. THE SYSTEM INCLUDES A VARIETY OF BONE SCREW SIZES LENGTHS AND DIAMETER AND MULTIPLE ROD MATERIAL OPTIONS 3 MATERIALS FOR DIFFERENT PATIENT NEEDS PER THE SURGEON''S PREFERENCE. THE INTERFACE OF THE SCREW, ROD, AND LOCKING CAP IS DESIGNED AND TESTED ACCORDING TO REQUIREMENTS.

    Description of Event or Problem · 1

    OSTEOPOROTIC PATIENT DIAGNOSED WITH SCOLIOSIS AND DEBALANCEMENT ON THE LEFT CONVEXITY PORTION OF THE SPINE. SURGERY PERFORMED IN THE CONTEXT OF SPONDYLOLISTHESIS L4-L5 WITH MATRIX SCREWS, RODS, LOCKING CAPS AND TRANSCONNECTOR AT L3 TO L5. SURGEON NOTED THAT THE RIGHT L3 PEDICLE SCREW HAD PULLED OUT OF THE BONE. PATIENT UNDERWENT REVISION SURGERY. DURING HARDWARE REMOVAL, THE L5 LOCKING CAP BECAME STUCK AND STRIPPED IN THE HEAD OF THE SCREW. SEVERAL INSTRUMENTS WERE USED TO REMOVE THE L5 LOCKING CAP, SCREW AND ROD. IT IS UNKNOWN IF THE L5 CAP, SCREW AND ROD WAS ON THE PATIENT'S LEFT OR RIGHT SIDE. PATIENT WAS REVISED TO USS DUAL OPENING SYSTEM FROM L2 TO L5 WITH HOOKS IN L5. THIS IS THE 1ST OF 5 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIX LOCKING CAP MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE 6776263

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SCREWS| RODS| TRANSCONNECTOR| LOCKING CAPS