ROD, 480 MM
Received Nov 7, 2021 · Event occurred Jan 1, 2021
Report 1526439-2021-02329 · MDR key 12759361
Device
Generic name
Orthosis, Spinal Pedicle Fixation, For Ddd
Manufacturer
Medos International Sã rl ChModel number
179762480Catalog number
179762480
Product problems
- Migration
- Migration
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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.
Description of Event or Problem
IT WAS FURTHER REPORTED THAT THE SURGEON DECIDED TO KEEP THE ROD AS IT IS. PATIENT OUTCOME IS REPORTED AS OKAY.
Additional Manufacturer Narrative
COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. HEALTH EFFECT: CLINICAL CODE (B)(4) USED TO CAPTURE: INJURY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, POST-OPERATIVELY THE RODS SLIDE OUT OF THE DISTAL (CAUDAL) SCREWS, DESPITE OF A DOUBLE CONTROL WITH THE TORQUE HANDLE. THE SURGEON DOES NOT SUSPECT A DEFECT WITH THE TORQUE HANDLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).