BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA SELECT

    MDR report key: 813880 · Received January 30, 2007

    Report

    Report Number
    2184052-2007-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2007
    Date of Event
    January 17, 2007
    Report Date
    January 17, 2007
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: REVIEW OF COMPLAINT TRENDING FOR THE PAST 36 MONTHS DID NOT REVEAL ANY FIELD REPORTS FOR THIS PART NUMBER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CERVICAL PLATE REMAINS IN THE PATIENT AND THE LOCKING CAP WAS DISPOSED OF BY THE HOSPITAL. ZIMMER SPINE OBTAINED INFORMATION FROM THE ZIMMER SPINE FIELD REP ON 22-JAN-07 THAT THE PATIENT DIED ONE DAY AFTER SURGERY. ON 22-JAN-07, COMMUNICATION WITH THE HOSPITAL CEO INFORMED ZIMMER SPINE THAT, BASED ON THE HOSPITALS INVESTIGATION, THE PATIENT EITHER SUFFERED A MYOCARDIAL INFARCTION OR PULMONARY EMBOLISM, AND THAT THE CONSTRUCT IMPLANTED IN 2007, MOST LIKELY DID NOT CONTRIBUTE TO OR CAUSE THE PATIENT'S DEATH. THE HOSPITAL REPORTED THAT NO AUTOPSY WAS PERFORMED, AT THE REQUEST OF THE PATIENT'S FAMILY. IT IS UNKNOWN IF THE PATIENT HAD ANY PRE-EXISTING HEALTH CONDITIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    SURGERY DATE IN 2007. PATIENT RECEIVED 46MM TRINICA SELECT CERVICAL PLATE WITH 6 SCREWS FROM C3 TO C5. THE CASE REP REPORTED THAT THE LOCKING CAP ON THE PLATE, AT C3 LEVEL, POPPED OUT OF THE PLATE WHEN THE SURGEON WAS ATTEMPTING TO ROTATE CAP OVER THE SCREW HEADS. DURING SURGERY, THE CASE REP CONTACTED ZIMMER SPINE MEDICAL EDUCATION DEPARTMENT TO OBTAIN RECOMMENDATION. THE MEDICAL EDUCATION REP INFORMED THE CASE REP THAT ZIMMER SPINE RECOMMENDS REPLACING THE PLATE. THE CASE REP FORWARDED THIS INFORMATION TO THE SURGEON DURING SURGERY. THE SURGEON DECIDED NOT TO REMOVE AND REPLACE THE PLATE BECAUSE HE FELT THE TWO SCREWS HAVE GOOD BONE PURCHASE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITH LESS THAN 10 MINUTES ADDITIONAL SURGERY TIME NEEDED. THE REP STATED THAT THE PLATE WAS NOT CONTOURED WITH INSTRUMENTATION AT ANY TIME DURING THE CASE. THE HOSPITAL DISPOSED OF THE LOCKING CAP AFTER SURGERY. THE CERVICAL PLATE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA SELECT TRINICA ANTERIOR CERVICAL PLATE SYSTEM KWQ ZIMMER SPINE 07.00341.005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *