OPTERYX
Received Dec 23, 2009 · Event occurred Dec 2, 2009
Report 3004719693-2009-00004 · MDR key 1565675
Device
Generic name
Cervical Plate
Manufacturer
Innovasis, Inc.Model number
13MM VARIABLE X 4Catalog number
CP2013
Lot number
0704
Product problems
- Break
- Detachment Of Device Component
Patient
34 YR
- Fall
- Neck Pain
Narrative
Additional Manufacturer Narrative
ADD'L LOT NUMBER 0801.
Description of Event or Problem
IN 2009, OUR DISTRIBUTOR REPORTED THAT HE WAS SENDING 4 BROKEN SCREWS, THREE UNBROKEN SCREWS AND A CERVICAL PLATE THAT HAD BEEN REMOVED FROM A PT. REVISION SURGERY HAD APPARENTLY BEEN PERFORMED IN MID NOVEMBER AFTER PT REPORTED NECK PAIN FOR SEVERAL WEEKS AFTER FALLING, APPROX EARLY OCTOBER. ORIGINAL FUSION SURGERY HAD BEEN EIGHT MONTHS AGO. X-RAY PRIOR TO REVISION SURGERY WAS RECEIVED AT INNOVASIS DAY OF REPORT. THIS SHOWED THE CERVICAL PLATE WITH BROKEN SCREWS AND THE LOWER PORTION OF THE PLATE SEPARATED FROM THE VERTEBRAE.