ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Report
- Report Number
- 2520274-2017-10941
- Event Type
- Injury
- Date Received
- March 21, 2017
- Report Date
- March 7, 2017
- Manufacturer
- SYNTHES USA
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- ATTORNEY
Narratives
PART NUMBER 498.571 LOT NUMBER 1436606 FOR 3-D HEAD AND PART NUMBER 498.570 AND TWO POSSIBLE LOT NUMBERS, 931519 & 9315194 WERE PROVIDED FOR TWO LOCKING CAPS. IT IS UNKNOWN IF THESE DEVICES WERE INVOLVED IN THIS CASE. ADDITIONAL QUANTITY OF LOCKING CAPS IS UNKNOWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT HEIGHT REPORTED AS 5¿5¿. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT AGE AND WEIGHT NOT AVAILABLE FOR REPORTING. EXACT DATE OF DEVICE BREAKAGE IS UNKNOWN. THIS REPORT IS FOR TWO UNKNOWN CLICKX PEDICLE SCREWS/UNKNOWN LOTS. UDI: PART NUMBER UNKNOWN, UDI UNAVAILABLE (THERAPY DATE): EXACT IMPLANT DATE IS UNKNOWN; REPORTED AS (B)(6) 2005¿ COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CORRECTED DATA: QUANTITY OF CONCOMITANT LOCKING HEAD CORRECTED TO FOUR (4) DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CONCOMITANT DEVICES THERAPY DATE REPORTED AS (B)(6) 2005. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT IS REPORTED THAT A PATIENT WITH MULTIPLE PREVIOUS SURGERIES, INCLUDING A DISCECTOMY AT C6-C7 IN 2001 (NECK) AND/OR 2003 SUSTAINED A SPINAL INJURY IN (B)(6) 2004. THE PATIENT HAD A LUMBAR LAMINECTOMY SURGERY IN 2005. IT IS NOT KNOWN WHAT WAS IMPLANTED IN EACH OF THESE PREVIOUS PROCEDURES BUT IN EARLY 2005, X-RAYS TAKEN ON UNKNOWN DATE REVEALED PATIENT HAD SEVERED HER SPINE. REPORTEDLY, THE PATIENT HAD FALLEN AT HER PLACE OF EMPLOYMENT AND INITIALLY THOUGHT SHE HAD SUSTAINED A NERVE INJURY. X-RAYS TAKEN ON OR ABOUT (B)(6) 2005, SHOWED THE PATIENT HAD GRADE 1 (BORDERING AT GRADE 2) SPONDYLOLISTHESIS AT L5-S1 (AT 25-35% SUBLUXATION) AND THAT SHE DID NOT HAVE ANY SIGNIFICANT MOTION IN FLEXION, NOR EXTENSION. MILD RETROLISTHESIS AT L4/5 WAS NOTED AND ON (B)(6) 2005, IT WAS SUSPECTED THAT THE PAIN SHE WAS EXPERIENCING WAS FROM HER BACK AND NOT A NERVE INJURY. MRI AND X-RAYS SHOWED SEVERE NEUROFORAMINAL NARROWING OF THE L5 NERVE ROOT AND LATERAL DISC PROTRUSION. THE PATIENT¿S PREOPERATIVE DIAGNOSIS INCLUDED THE GRADE I SPONDYLOLISTHESIS ALONG WITH BILATERAL L5 ¿ S1 EXTREME LATERAL DISC HERNIATIONS WITH BILATERAL NEURAL COMPRESSION AND SPINAL STENOIS WITH S1 NEURAL COMPRESSION. IT WAS DETERMINED THAT THE PATIENT REQUIRED SCREW FIXATION AND ON (B)(6) 2005, THE PATIENT UNDERWENT SURGERY TO IMPLANT FOUR (4) CLICKX PEDICLE SCREWS AT L5 TO S1. ACCORDING TO THE OPERATIVE REPORT, ¿THE DEFECT WAS TEMPLATED WITH AND A 13 MM TRANSFORAMINAL LUMBAR INTERBODY ARTHRODESIS MASS WAS THEN FASHIONED, PLACING THE BONE MIXTURE IN THE WOUND. THE POSTERIOR LUMBAR INTERBODY FUSION (PLIF) IMPLANT WAS PLACED IN THE DISC SPACE ALONG WITH A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ARTHROXESIS IMPLANT. THE SURGEON THEN PLACED 6.5 X 55MM SCREWS IN L5 BILATERALLY, AND 6.5 X 50 MM SCREWS WERE PLACED AT S1 BILATERALLY. THE ENDCAP WAS PLACED DOWN TO S1 AND THE APPROPRIATE PLATE WAS PLACED UP AT THE END CAPS AND THEN A TORQUE. X-RAYS TAKEN ON OR ABOUT (B)(6) 2005, SHOWED THE PATIENT STILL HAS SOME MILD ROTATOR SCOLIOSIS PRESENT EVEN AFTER SHE HAD UNDERGONE A LEFT-SIDED TRANSFORAMINAL IMPLANTATION. ON OR ABOUT (B)(6) 2006, THE PATIENT WAS NOTED AS WELL TO HAVE AN IATROGENIC LAMINECTOMY DEFECT ALONG WITH HER CONGENITAL ABNORMALITIES. X-RAY TAKEN AT TWELVE-MONTH FOLLOW-UP REVEALED THE HEAD OF BOTH SCREWS AT L5 WERE BROKEN. THE PATIENT WAS ADVISED THAT SURGERY WAS RECOMMENDED; A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WITH A ROD SYSTEM. THE PATIENT WAS RETURNED TO SURGERY ON AND THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2006 WHERE THE SURGEON REMOVED THE BROKEN SCREWS AT L5 AND REPLACED THEM WITH LARGER DIAMETER CLICK¿X SCREWS. CONCOMITANT DEVICES REPORTED: CLICKX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 2), CLICKX ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 2), CLICKX LOCKING CAP (PART NUMBER: 498.570 UNKNOWN, POSSIBLE LOT NUMBER 931519 & 9315194, QUANTITY 4), LOCKING HEAD (PART NUMBER: 498.571, LOT NUMBER: 1436606, QUANTITY 1), TLIF IMPLANT (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: UNKNOWN), PLIF IMPLANT (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: UNKNOWN), ALLOGRAFT (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: UNKNOWN).
IT IS REPORTED PATIENT SUSTAINED A SPINAL INJURY IN (B)(6) 2004. IN EARLY 2005, X-RAYS TAKEN ON UNKNOWN DATE REVEALED PATIENT HAD SEVERED HER SPINE. ON (B)(6) 2005, PATIENT UNDERWENT SURGERY TO IMPLANT FOUR (4) CLICKX PEDICLE SCREWS AT L5 TO S1. X-RAY TAKEN AT TWELVE MONTH FOLLOW UP REVEALED THE HEAD OF BOTH SCREWS AT L5 WERE BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2006 WHERE SURGEON REMOVED THE SCREWS AT L5 AND REPLACED THEM WITH LARGER DIAMETER CLICKX SCREWS. CONCOMITANT DEVICES REPORTED: CLICKX ROD. CLICKX LOCKING CAP. THIS REPORT IS FOR TWO UNKNOWN CLICKX PEDICLE SCREWS.¿ THIS IS REPORT 1 OF 1 FOR (B)(4).
CONCOMITANT DEVICES REPORTED: LOCKING HEAD (PART NUMBER: 498.571, LOT NUMBER: 1436606, QUANTITY 4)
CONCOMITANT DEVICES REPORTED: CLICKX ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN); CLICKX LOCKING CAP (PART NUMBER 498.570, POSSIBLE LOT NUMBER 931519 & 9315194, QUANTITY UNKNOWN); 3-D HEAD (PART NUMBER 498.571, LOT NUMBER 1436606, QUANTITY 1).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204023 | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD | NKB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CLICKX LOCKING CAP| CLICKX ROD |