BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2141758 · Received June 27, 2011

    Report

    Report Number
    1030489-2011-00819
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    November 2, 2011
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    KWP
    PMA / PMN Number
    K081297
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE CROWN IS SHOWING IMPACTIONS DUE TO TIGHTENING WITH A SPINAL ROD. THE DEFORMATIONS ARE ASYMMETRICAL FOR THREE MAS REFERENCE (B)(4), CONSISTENT WITH THE TRANSMISSION OF FLEXURAL LOADS THROUGH THE CONNECTION WHEREAS THE DEFORMATIONS ARE SYMMETRICAL FOR TWO MAS REFERENCE (B)(4), CONSISTENT WITH THE PROPER TIGHTENING OF THE CONNECTION. ALL SETSCREWS (FOR DOMINOS AND FOR MAS) PRESENT WORN SURFACES AT THE FLAT BOTTOM WHICH ARE CONSISTENT WITH THE TIGHTENING OF THE RODS. THE SHORTEST ROD PRESENTS ONE MARK COMING FROM THE MAS SETSCREWS AND ONE MARK COMING FROM THE DOMINO SETSCREW AT ITS POSTERIOR SIDE. AT ITS OPPOSITE ANTERIOR SIDE, THIS ROD PRESENTS ONE CONTACT WITH THE MAS CROWN AND TWO LINES OF CONTACT WITH THE DOMINO ROD CANAL. THE ROD END CLOSED TO THE CONTACT WITH THE DOMINO HAS BEEN CUT WITH A ROD CUTTER. THE ROD IS BROKEN AT THE OPPOSITE END (CLOSED TO THE MAS CONTACT). THE FRACTURE APPEARANCE IS TYPICAL OF FATIGUE DAMAGING OF THE MATERIAL WITH VISIBLE LINES OF REST ACROSS THE SECTION. THE LONGEST ROD IS BROKEN IN TWO AT THE JUNCTION BETWEEN THE Ø3.2 AND Ø3.6 PORTIONS. THE FRACTURE IS ORTHOGONAL TO THE ROD DIRECTION. BOTH ENDS OF THE LONGEST ROD HAVE BEEN CUT WITH A ROD CUTTER. THE Ø3.6 PORTION PRESENTS ONE MARK COMING FROM A SETSCREW AT ITS POSTERIOR SIDE. THE BROKEN SURFACE IS FULLY WORN DUE TO REPETITIVE CONTACTS BETWEEN THE TWO BROKEN SECTIONS OF THE ROD. THE Ø3.2 PORTION PRESENTS SEVERAL MARKS COMING FROM THE SETSCREW AT ITS POSTERIOR SIDE AND SEVERAL CONTACTS WITH THE MAS CROWN AT ITS ANTERIOR SIDE (SOME MARKS AND CONTACTS APPEAR TWICE WHICH MAY CORRESPOND TO THE PRELIMINARY AND THE FINAL TIGHTENING). THE FRACTURE APPEARANCE IS TYPICAL OF FATIGUE DAMAGING OF THE MATERIAL WITH VISIBLE LINES OF REST ACROSS THE SECTION. THE FRACTURE APPEARANCE PRESENTS WORN SURFACE AT THE PERIPHERY OF THE SECTION DUE TO REPETITIVE CONTACTS BETWEEN THE TWO BROKEN SECTIONS OF THE ROD. NO PRE-EXISTING DEFECTS HAVE BEEN IDENTIFIED ON THE IMPLANTS THAT COULD BE RESPONSIBLE OF THE EVENT. THE RODS SHOWS TYPICAL METAL FATIGUE DAMAGING DUE TO OVERLOAD APPLIED ON THE SPINAL CONSTRUCT. THE FULL WORN SURFACE AT THE BROKEN SECTION OF THE LONGEST ROD DUE TO REPETITIVE CONTACTS BETWEEN THE TWO BROKEN SECTIONS OF THE ROD SUGGEST THAT THE INITIAL SURGERY HAS BEEN PERFORMED PRIOR THE SURGERY DATE REPORTED IN THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL FUSION PROCEDURE WITH POSTERIOR FIXATION. IT WAS NOTED SOMETIME POST-OP THAT THE DEVICE HAD MIGRATED. A REVISION SURGERY REPORTEDLY TOOK PLACE 14 DAYS POST-OP. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS, INC. W08H4428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention