EXCELLA-P
Received Sep 5, 2008 · Event occurred Aug 4, 2008
Report 3004719693-2008-00001 · MDR key 1153244
Device
Generic name
Pedicle Screw System
Manufacturer
Innovasis, Inc.Model number
6.5 X 40MMCatalog number
EP6540
Lot number
0701
Product problems
- Explanted
- Loose
Patient
57 YR
- Pain
- Surgical procedure, repeated
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
FIVE MONTHS AFTER IMPLANT FOR SPINAL FUSION, PATIENT COMPLAINED OF PAIN. X-RAY REVEALED LOCKING CAP OF PEDICLE SCREW HAS COME LOOSE.
Additional Manufacturer Narrative
EVALUATION OF RETURNED UNIT INCLUDED TESTING THE INTERNAL THREADS OF THE DRIVER BODY WITH GO AND NO-GO PLUG GAGES. THE NO-GO GAGE COULD, WITH MODERATE EFFORT, BE INSERTED INTO THE DRIVER BODY. THE DHR FOR THIS LOT WAS ICN 00693, WHICH INCLUDED AN NCMR (NON-CONFORMING MATERIAL REPORT) FOR THIS CHARACTERISTIC . THAT LOT WAS SUBJECTED TO 100% INSPECTION AND ONLY UNITS THAT WOULD NOT ACCEPT THE GAGE WERE RELEASED FOR DISTRIBUTION. THE SCREW AND LOCKING CAP WERE ASSEMBLED TO A 6MM ROD AND FOUND TO FUNCTION WELL AT THE PRESCRIBED TORQUE OF 80 INCH-POUNDS. IT APPEARS THAT THE SCREW WAS SLIGHTLY SPRUNG DURING INSERTION OR THE PERIOD OF IMPLANTATION BUT WOULD STILL ACCEPT THE SPECIFIED TORQUE. THE EVALUATION WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP LOOSENED.