CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2021-00182
- Event Type
- Malfunction
- Date Received
- February 11, 2021
- Report Date
- March 23, 2021
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H6: FDM CODE UPDATED AS PER NEW INFORMATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IMPLANT DATE IS (B)(6) 2019.
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCT IS NOT MARKETED IN US. 510(K) FOR SIMILAR PRODUCT MARKETED IN US WITH CATALOGUE# 70468580 IS K050439. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF SCREW BACK OUT AND ROD BROKEN. IT WAS A REVISION SURGERY. INITIAL SURGERY IS DONE ON (B)(6) 2016, TLIF WAS PERFORMED ON ONE INTERVERTEBRAL DISC. ON (B)(6) 2017, REOPERATION WAS PERFORMED ON T4-S2AI. ON (B)(6) 2017, REPLACEMENT OF VERTEBRAL BODY WAS PERFORMED BECAUSE L4 WAS COLLAPSED. ON (B)(6) 2019, S1 AND S2AI SCREWS WERE REPLACED (SET SCREW BACKED OUT). ON (B)(6) 2019, S1 AND S2AI SCREW REPLACEMENT + EXTENSION TO IL (BECAUSE SET SCREW BACKED OUT). IT WAS REPORTED THAT THE SET SCREW ON THE C SIDE OF THE MRC O / C INSERTED BETWEEN THE LEFT L2 AND L3 BACKED OUT. ROD WAS BROKEN BETWEEN LEFT L3-4.LEGACY CLOSED MAS F8.5X80 SCREW OF THE LEFT S2AI WAS BROKEN ON THE BASE. ROD WAS BROKEN BETWEEN THE RIGHT L2-3.SET SCREW OF THE RIGHT S1 BACKED OUT. LEGACY CLOSED MAS F8.5X80 SCREW OF THE RIGHT S2AI WAS BROKEN ON THE BASE. HENCE ON (B)(6) 2021, ALL THE RODS, CONNECTORS, AND LEGACY CLOSED MAS WERE REMOVED AND REPLACED, AND THE OPERATION WAS COMPLETED. THERE WERE FRAGMENTS OF THE IMPLANTS REMAINED IN THE PATIENT BODY. TWO S2AI LEGACY CLOSED MAS8.5X80 SCREWS REMAINING IN THE SACRAL ILIAC PART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211333 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | GX70468580 | 0272863W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |