CD HORIZON® SPINAL SYSTEM
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Report
- Report Number
- 1030489-2024-00184
- Event Type
- Malfunction
- Date Received
- March 20, 2024
- Date of Event
- May 31, 2023
- Report Date
- June 3, 2025
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- UDI-DI
- 00643169004344
- PMA / PMN Number
- K113174
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4: IT WAS UNKNOWN WHETHER THE LOT#H5724022 OR LOT#H5759696 HAS THE MALFUNCTION. HENCE, BOTH THE LOT NUMBERS WERE REPORTED. 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 RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF A PATIENT WITH CLINICAL PATIENT ID (B)(6), STUDY ID (B)(6). EVENT: IT WAS REPORTED THAT, ON (B)(6) 2023 PATIENT REPORTED NEW LEFT BUTTOCK PAIN THAT STARTED ABOUT 2 MONTHS AGO, REPORTS THAT PAIN IS ACHY AND RUNS DOWN LEFT LOWER EXTREMITY (LLE). SITE RELATED ASSESSMENT: POSSIBLY RELATED TO INTERBODY FUSION, POSTERIOR FIXATION AND SURGICAL PROCEDURE. NOT RELATED TO PLF GRAFTING MATERIAL AND RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. SPONSOR ASSESSMENT: YES DESCRIPTION: LEFT BUTTOCK PAIN WITH RADIATION. ONSET DATE: (B)(6) 2023, DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUB-TYPE : L-SPINE 4 VW-1 ACTION DATE : (B)(6) 2023, INTERVENTIONS : ACTION SUBTYPE : OTHER ACTION RESULT: Y- FILM CONFERENCE TO REVIEW/READ STUDY CT FROM (B)(6) 2023. SHOULD AVOID BENDING AT BACK <(>&<)> BEND FROM THE KNEES TO AVOID BACK INJURY, SHOULD HOLD OFF ON ACTIVITIES SUCH AS KAYAKING UNTIL RADIOLOGIST READS CT. ADDITIONAL INFORMATION RECEIVED ON 2024-FEB-29: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE 4 VW-1 ACTION RESULT: NORMAL ACTION DATE: 2023-07-31, ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: STUDY (B)(6) ACTION RESULT: ABNORMAL, ACTION DATE: 2023, ACTION INFO: DIAGNOSTIC TESTS PERFORMED: SMALL AMOUNT OF LUCENCY ON S1 SCREWS. ADDITIONAL INFORMATION RECEIVED ON 08-MAR-2024: SITE ASSESSMENT: POSSIBLY RELATED TO PROCEDURE, PLF GRAFTING MATERIAL, POSTERIOR FIXATION AND NOT RELATED TO INTERBODY FUSION DEVICE. SPONSOR ASSESSMENT: NOT RELATED TO PLF GRAFTING MATERIAL, INTERBODY FUSION, SURGICAL PROCEDURE AND POSSIBLY RELATED TO POSTERIOR FIXATION. PROCEDURE DATE: (B)(6) 2022 TARGET LEVELS: L4/L5; L5/S1 ADDITIONAL INFORMATION RECEIVED. THERE WAS NO PLAN TO PERFORM REVISION SURGERY TO EXPLANT THE S1 SCREW.
ADDITIONAL INFORMATION RECEIVED STATING CEC ASSESSMENT AS POSSIBLE RELATED TO THE PROCEDURE, TO THE POSTERIOR LUMBAR INTERBODY GRAFTING MATERIAL, TO THE POST FIXATION AND TO THE INTERBODY DEVICE. NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THAT, THE OUTCOME STATUS WAS UPDATED TO RESOLVED AND THE OUTCOME DATE WAS (B)(6) 2025. ON (B)(6) 2023-PATIENT REPORTED NEW LEFT BUTTOCK PAIN THAT STARTED ABOUT 2 MONTHS AGO, REPORTS THAT PAIN IS ACHY AND RUNS DOWN LEFT LEG EXTREMITY. AS OF (B)(6) 2024- PATIENT WAS STILL HAVING PAIN. ETIOLOGY WAS UNKNOWN AT THIS TIME, (B)(6) 2025- PER PATIENT HIP PAIN HAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535757 | CD HORIZON® SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | 55840007545 | H5724022 | 00643169004344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |