BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3150192 · Received June 6, 2013

    Report

    Report Number
    1719045-2013-01538
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED PRODUCT, AT THE THREADED TIP OF THE INNER SLEEVE, IS BROKEN ON THE VERY DISTAL TIP. AREA NEAR THREADED TIP IS HAS A WARN APPEARANCE. MAGNUM MANUFACTURED THE RETAINING SLEEVE ¿ FOR MATRIX. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP BROKE. THE MATERIAL OF THE INNER SLEEVE WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE THREADS, THREADED TIP DEPTH AND LOCATION WERE UNABLE TO BE VERIFIED DUE TO THE DAMAGE ON THE TIP. THE PARTS ALL PASSED INSPECTION AT THE TIME OF MANUFACTURING. 03.632.001 IS A LOCKING HOLDING SLEEVE FOR THE MATRIX PEDICLE SCREW SYSTEM. IMPROPER USE OF THIS HOLDING SLEEVE CAN CONTRIBUTE TO THE HAZARD EXPERIENCED IN THIS COMPLAINT. THE TECHNIQUE GUIDE ILLUSTRATES HOW TO PROPERLY LOAD AND TIGHTEN THE HOLDING SLEEVE INTO THE RECESS OF THE SCREW AND CAUTIONS NOT TO GRASP THE GREEN KNOB DURING SCREW INSERTION AS THIS WILL CAUSE THE HOLDING SLEEVE TO DISENGAGE FROM THE SCREW. THE LOT FOR THIS COMPLAINT IS (B)(4). SYNTHES RECEIVED THIS LOT IN (B)(4) 2011. THIS DATE IS PRIOR TO THE CHANGES IMPLEMENTED AS A RESULT OF CAPA (B)(4). THE CHU REVIEWED THE COMPLAINT HISTORY FOR THIS HAZARD FROM (B)(4) 2011 TO (B)(4) 2013. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2013 FOR A TWO-LEVEL VERTEBRAL SPACER TR SURGERY AT L3-L5 LEVELS. PATIENT PRESENTED WITH PAIN. X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED THE TWO MATRIX SCREWS AT L3 BACKED OUT. FOR THE INITIAL SURGERY, IT WAS REPORTED THE SURGEON PACKED BONE AND THE SPACER WAS BEHIND THE BONE GRAFT; THE SPACER SHIFTED. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. REPORTEDLY WHILE THE SURGEON WAS REMOVING THE L4 LOCKING CAP ON THE LEFT SIDE OF THE SPINE USING THE STRAIGHT TIP DRIVER T25, THE TIP OF THE DRIVER BROKE. SURGEON REMOVED THE FRAGMENT WITH A PITUITARY INSTRUMENT. THE SURGEON TRIED TO REMOVE THE LOCKING CAP WITH ANOTHER STRAIGHT TIP DRIVER T25 AND THE TIP OF THE DRIVER BROKE. THE SURGEON WAS REMOVED THE FRAGMENT WITH A BAYONET INSTRUMENT. THE SURGEON THEN TRIED TO REMOVE THE LOCKING CAP WITH A T-HANDLE STARDRIVE SHAFT AND THE SHAFT BROKE IN HALF. IT WAS REPORTED WHILE THE SURGEON WAS USING THE ROD BENDER WITH SILICONE HANDLES FOR CONTOURING THE NEW RODS, THE HANDLES BECAME STUCK. ANOTHER INSTRUMENT WAS USED TO BEND THE RODS. THE SURGEON REMOVED THE T-PLIF SPACER, SCREWS, AND RODS AT L3-4 LEVEL. REPORTEDLY THE T-PLIF SPACER WAS REMOVED DUE TO THE IMPLANT SHIFTING. THE PATIENT WAS REVISED WITH TWO NEW SCREWS AND RODS. TWO ADDITIONAL SCREWS WERE ADDED TO THE CONSTRUCT AT THE ILEUM LEVEL. REPORTEDLY THERE WAS EXTENDED TIME OF TWO HOURS DUE TO THE DEVICE MALFUNCTION. THIS IS 6 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250170 HOLDING SLEEVE-STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6489721

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention