BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION

    MDR report key: 359752 · Received November 1, 2001

    Report

    Report Number
    2246640-2001-00001
    Event Type
    Malfunction
    Date Received
    November 1, 2001
    Date of Event
    January 1, 2001
    Report Date
    October 31, 2001
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MNI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SINGLE REPORT INVOLVING THREE (3) PTS WAS REC'D FROM AN INDIVIDUAL SURGEON USING THE SUBJECT SPINAL INSTRUMENTATION SYSTEM FOR THE FIRST TIME. THE PTS UNDERWENT A SPINAL FUSION PROCEDURE WITH THE SYSTEM WHICH ENTAILED INTRAOPERATIVE ASSEMBLY OF VARIOUS SYSTEM COMPONENTS INCLUDING SCREWS, SCREW CAPS AND RODS. SURGEON NOTED ON POSTOPERATIVE RADIOGRAPHS THAT ONE OF THE SCREW CAP/ROD ASSEMBLIES IN EACH PT WAS NOT CONNECTED TO THE SCREW HEAD AS IT SHOULD HAVE BEEN. IN ATLEAST TWO OF THE THREE PTS, SURGEON COULD NOT DETERMINE WHETHER THIS OCCURRED INTRAOPERATIVELY (I.E. INADEQUATE ASSEMBLY) OR POSTOPERATIVELY. IN THE THIRD CASE, SURGEON BELIEVED THAT SEPARATION OF SCREW CAP FROM SCREW HEAD OCCURRED POSTOPERATIVELY. SURGEON REPORTED THAT THE PT STILL HAD A SECURE CONTRALATERAL SIDE FIXATION AND WERE DOING WELL. NO REVISION SURGERY WAS INDICATED.

    Description of Event or Problem · 2

    A SINGLE REPORT INVOLVING THREE (3) PTS WAS REC'D FROM AN INDIVIDUAL SURGEON USING THE SUBJECT SPINAL INSTRUMENTATION SYSTEM FOR THE FIRST TIME. THE PTS UNDERWENT A SPINAL FUSION PROCEDURE WITH THE SYSTEM WHICH ENTAILED INTRAOPERATIVE ASSEMBLY OF VARIOUS SYSTEM COMPONENTS INCLUDING SCREWS, SCREW CAPS AND RODS. SURGEON NOTED ON POSTOPERATIVE RADIOGRAPHS THAT ONE OF THE SCREW CAP/ROD ASSEMBLES IN EACH PT WAS NOT CONNECTED TO THE SCREW HEAD AS IT SHOULD HAVE BEEN. IN ATLEAST TWO OF THE THREE PTS, SURGEON COULD NOT DETERMINE WHETHER THIS OCCURRED INTRAOPERATIVELY (I.E., INADEQUATE ASSEMBLY) OR POSTOPERATIVELY. IN THE THIRD CASE, SURGEON BELIEVED THAT SEPARATION OF SCREW CAP FROM SCREW HEAD OCCURRED POSTOPERATIVELY. SURGEON REPORTED THAT PTS STILL HAD A SECURE CONTRALATERAL SIDE FIXATION AND WERE DOING WELL. NO REVISION SURGERY WAS INDICATED.

    Description of Event or Problem · 3

    A SINGLE REPORT INVOLVING THREE (3) PTS WAS REC'D FROM AN INDIVIDUAL SURGEON USING THE SUBJECT SPINAL INSTRUMENTATION SYSTEM FOR THE FIRST TIME. THE PTS UNDERWENT A SPINAL FUSION PROCEDURE WITH THE SYSTEM WHICH ENTAILED INTRAOPERATIVE ASSEMBLY OF VARIOUS SYSTEM COMPONENTS INCLUDING SCREWS, SCREW CAPS AND RODS. SURGEON NOTED ON POSTOPERATIVE RADIOGRAPHS THAT ONE OF THE SCREW CAP/RODS ASSEMBLIES IN EACH PT WAS NOT CONNECTED TO THE SCREW HEAD AS IT SHOULD HAVE BEEN. IN ATLEAST TWO OF THE THREE PTS, SURGEON COULD NOT DETERMINE WHETHER THIS OCCURRED INTRAOPERATIVELY (I.E. INADEQUATE ASSEMBLY) OR POSTOPERATIVELY. IN THE THIRD CASE, SURGEON BELIEVED THAT SEPARATION OF SCREW CAP FROM SCREW HEAD OCCURRED POSTOPERATIVELY. SURGEON REPORTED THAT PTS STILL HAD A SECURE CONTALATERAL SIDE FIXATION AND WERE DOING WELL. NO REVISION SURGERY WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49029 OVATION SPINAL FIXATION SYSTEM MNI OSTEOTECH, INC. 2122 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other
    2 74 YR Other
    3 24 YR Other