CD HORIZON® SPINAL SYSTEM
Report
- Report Number
- 2647346-2025-00151
- Event Type
- Malfunction
- Date Received
- October 17, 2025
- Date of Event
- September 15, 2025
- Report Date
- December 2, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., HU
- Product Code
- KWP
- UDI-DI
- 00643169004344
- PMA / PMN Number
- K113174
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
L2 AND PELVIC SCREWS WERE LOOSE IN THE SAME PATIENT/EVENT. THE SPECIFIC IDENTIFIERS OF THE LOOSE SCREWS COULD NOT BE CONFIRMED. THE FOLLOWING PRODUCT IDS AND LOT NUMBERS WERE PRESENT AT IMPLANT: [LIST ALL OTHER 11]. THE FAILED SCREWS¿ EXACT SERIAL/LOT/UDI-PI REMAIN UNKNOWN. PRODUCT ID:, LOT#:, UDI:, 510(K) 55840007545, H5332527, 643169004344, K113174, 55840007545, 0217834W, 643169004344, K113174, 55840007545, H5326897, 643169004344, K113174, 55840007550, H5753508, 643169004351, K113174, (QTY-2), 25630018580, CA16L048, 643169412620, K153442, 25630018580, CA21M059, 643169412620, K153442, 55840006545, H5648850, 613994971753, K113174, 55840006545, H5659108, 613994971753, K113174, 55840007545, H5233246, 643169004344, K113174, 55840007545, H13G0838, 643169004344, K113174. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B5.DESC EVT PROBLEM UPDATED MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B5.DESC EVT PROBLEM UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6). ON (B)(6) 2025, A CT (DIAGNOSTIC) REPORTED ABNORMAL FINDINGS WITH HALOING AROUND THE L2 AND PELVIC SCREWS CONSISTENT WITH SCREW LOOSENING, WITH PELVIS INSTRUMENTATION IN PLACE AND EARLY PARTIAL FUSION NOTED. THE PATIENT HAS A HISTORY OF LUMBAR SURGERY (LAMINECTOMIES IN 1999 AND 2000 AT L4/L5¿L5/S1). THE PRIMARY DIAGNOSTIC INDICATION WAS STENOSIS WITH DOCUMENTED PRE-OPERATIVE INSTABILITY, WITH FOUR CONSECUTIVE LEVELS (L2¿S1) TREATED. SITE ASSESSMENT INDICATED A CAUSAL RELATIONSHIP TO THE INTERBODY FUSION DEVICE, POSTERIOR FIXATION DEVICE, PLF GRAFTING MATERIAL, AND THE SURGICAL CONSTRUCT/PROCEDURE. SPONSOR ASSESSMENT CONCLUDED THE EVENT IS CAUSALLY RELATED TO THE POSTERIOR FIXATION DEVICE AND NOT RELATED TO THE PROCEDURE, PLF GRAFTING MATERIAL, OR THE INTERBODY DEVICE. NO ADDITIONAL CLINICAL SYMPTOMS OR COMPLICATIONS WERE PROVIDED IN THE REPORT.
2025 OCT 18, UPDATE RECEIVED: THERE WERE NO SYMPTOMS RELATED SCREW LOOSENING- OVERALL PATIENT IS BETTER. 2025 OCT 29, UPDATE RECEIVED: ON (B)(6) 2025, DIAGNOSTIC X-RAY (XR-2) WAS ABNORMAL, SHOWING DEXTROSCOLIOSIS; SPINAL ALIGNMENT AND INSTRUMENTATION WERE ADEQUATE FROM L2 TO THE PELVIS, WITH INSTABILITY NOTED AT L1¿L2.
2025 NOV 13, UPDATE RECEIVED: CEC ASSESSMENT: CAUSAL RELATED TO THE POSTERIOR FIXATION AND TO THE PROCEDURE AND NOT RELATED TO THE PLF GRAFTING AND TO THE INTERBODY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299156 | CD HORIZON® SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC PUERTO RICO OPERATIONS CO., HU | 55840007545 | H5746549 | 00643169004344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |