BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP F/URS

    MDR report key: 3195448 · Received June 28, 2013

    Report

    Report Number
    2520274-2013-02675
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    December 8, 2010
    Manufacturer
    SYNTHES, USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THIS REPORT IS FOR FOUR DIFFERENT CAPS FOR DIFFERENT LOT NUMBERS (2X 04.636.001 LOT# 3133236 AND 2X 04.636.001 LOT# 3253291) RECEIVED FOR INVESTIGATION, HOWEVER, BUT IT WAS NOT IDENTIFIED AS TO WHICH SCREW CONTRIBUTED TO THE REPORTED INCIDENT. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. ADDITIONAL EVALUATION- THE BROKEN ROD HAS BEEN EXAMINED BY INTERNAL MATERIAL SCIENCE DEPARTMENT WITH BOTH A CROSS-SECTIONAL AS WELL AS LONGITUDINAL POLISH. THE EXAMINATION OF THE RAW MATERIAL USED DID NOT RESULT IN FINDINGS OF ANY IRREGULARITIES. THUS IT CAN BE SAID THAT THE IMPLANT MATCHES INTERNATIONAL STANDARDS AND AO SPECIFICATIONS. THE X-RAY SHOWED THAT THE LOCKING CAP HAD LEFT ITS ORIGINAL POSITION INSIDE THE SCREW HEAD POST-OPERATIVELY. IT SEEMED AS IF THE SET SCREW (INNER PART) OF THIS LOCKING CAP TURNED BACK COMPLETELY. MOST PROBABLY, THE FINAL TIGHTENING TO 10 NM AS DESCRIBED IN THE SURGICAL TECHNIQUE GUIDE, STEP 11 FINAL TIGHTENING OF INNER PART OF LOCKING CAP HAS NOT TAKEN PLACE. THE ROD BREAKAGE IS THE RESULT OF INCOMPLETE TIGHTENING OF THE LOCKING CAP.

    Description of Event or Problem · 1

    THE URS SYSTEM WAS IMPLANTED IN THE PATIENT ON (B)(6) 2009. IN THE X-RAY TAKEN POST OPERATION, DOCTOR NOTICED THAT ONE URS CAP HAD POPPED OFF AT THE CRANIAL END OF THE CONSTRUCT. NOT LONG FOLLOWING THIS THE ROD ON THE OPPOSITE SIDE BROKE AND THE PATIENT ALSO PRESENTED WITH SIGNIFICANT KYPHOSIS REQUIRING REVISION/ REPLACEMENT OF SCREWS ON (B)(6) 2010. THIS IS 4 OF 4 REPORTS FOR A CAP FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296540 LOCK-CAP F/URS HWC SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention