CD HORIZON SOLERA
Report
- Report Number
- 1030489-2025-02235
- Event Type
- Injury
- Date Received
- June 16, 2025
- Date of Event
- May 8, 2024
- Report Date
- January 28, 2026
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4, G4: PRODUCT IDENTIFIERS ARE UNKNOWN. H6 - 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. 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.
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.
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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: (B)(4) HAVING SPINAL THERAPY FOR INSTABILITY. IT WAS REPORTED THAT AT 6 MONTH CLINIC VISIT, PATIENT HAD NEW ONSET LOW BACK PAIN FOR THE LAST MONTH. X-RAYS PERFORMED WERE REPORTEDLY NORMAL. MRI ORDERED AND PER PI WERE ALSO NORMAL. DESCRIPTION: L3-4 DEGENERATIVE FACET DISEASE ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: Y IF YES, LEVELS INVOLVED: L3-L4 ADD SURGICAL PROC DATE - 01: ON (B)(6) 2024, DETAILS SURG PROC - 01: L3-4 TRANSFORAMINAL LUMBAR INTERBODY FUSION, IS THE ADDITIONAL SURGICAL PROCEDURE AN ELECTIVE REMOVAL - 01: N. DOES THE ADDITIONAL SURGICAL PROCEDURE INVOLVE A SPINAL LEVEL - 01: Y ADD. SURG: IF YES, LEVELS INVOLVED - 01: L3-L4, DOES THE ADDITIONAL SURGICAL PROCEDURE INVOLVE AN EXPLANT RELATED TO THE STUDY PROCEDURE - 01: N. SITE SERIOUSNESS ASSESSMENT: SEVERITY OF EVENT: SEVERE. SITE RELATED ASSESSMENT: NOT RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TLIF GRAFTING MATERIAL AND PROCEDURE. SITE RELATED ASSESSMENT FOR ADDITIONAL SURGERY: NOT RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TLIF GRAFTING MATERIAL AND PROCEDURE. OUTCOME STATUS: RESOLVED/ RECOVERED. OUTCOME DATE: ON (B)(6) 2024. SITE SERIOUSNESS ASSESSMENT: MEDICAL INTERVENTION: Y INTERVENTION: ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT, ACTION RESULT: Y, ACTION SUBTYPE: SURGICAL TREATMENT, ACTION RESULT: YES DIAGNOSTICS: ACTION. TYPE: DIAGNOSTIC, ACTION SUBTYPE: X-RAY2, ACTION RESULT: NORMAL, ACTION DATE: ON (B)(6) 2024; ACTION TYPE: DIAGNOSTIC, ACTION SUBTYPE: MRI WITH CONTRAST1, ACTION RESULT: NORMAL, ACTION DATE: ON (B)(6) 2024; ACTION TYPE: DIAGNOSTIC, ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED, ACTION RESULT: Y. SPONSOR AND CEC ASSESSMENT: POSSIBLE RELATED TO PROCEDURE, NOT RELATED TO TLIF GRAFTING MATERIAL, IBFD, AND POSSIBLE RELATED TO FIXATION SYSTEM. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
SITE RELATED ASSESSMENT FOR ADDITIONAL SURGERY: POSSIBLE RELATED TO STUDY PROCEDURE: RELATED TO FIXATION, SCREW PLACEMENT. SITE RELATED ASSESSMENT: POSSIBLE RELATED TO STUDY PROCEDURE: FIXATION, SCREW PLACEMENT.
SITE RELATED ASSESSMENT FOR ADDITIONAL SURGERY: NOT RELATED TO STUDY PROCEDURE. SITE RELATED ASSESSMENT: NOT RELATED TO STUDY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957641 | CD HORIZON SOLERA | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | MSB_UNK_HDWR_CDH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention |