V-LOX SUTURE ANCHOR
Report
- Report Number
- 3007319107-2023-00009
- Event Type
- Malfunction
- Date Received
- March 17, 2023
- Date of Event
- February 22, 2023
- Report Date
- April 25, 2023
- Manufacturer
- PARCUS MEDICAL LLC
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. ADDITIONAL INFORMATION HAS BEEN SOLICITED. A VIGILANCE REPORT WAS SUBMITTED TO THE FRENCH HEALTH AUTHORITY ON REPORT NUMBER (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT.
THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. ADDITIONAL INFORMATION HAS BEEN SOLICITED. A VIGILANCE REPORT WAS SUBMITTED TO THE FRENCH HEALTH AUTHORITY ON REPORT NUMBER (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT WAS CONFIRMED BASED ON THE X-RAY IMAGES PROVIDED WHICH ILLUSTRATED THAT THE ANCHOR DISLODGED FROM THE PATIENT'S BONE. THERE WAS NO REPORT OF ANY MALFUNCTION OR COMPLICATIONS FROM THE CUSTOMER AT THE TIME OF THE INITIAL IMPLANTATION OF THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT IMPACT, PRODUCT LOT NUMBER AND CURRENT STATUS OF THE PATIENT. INFORMATION WAS NOT PROVIDED WHEN SOLICITED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. IT WAS REPORTED TO PARCUS MEDICAL LLC THAT A 5.0 TITANIUM ANCHOR PULLED OUT OF THE PATIENTS SHOULDER POST-OPERATIVELY. AN X-RAY WAS PROVIDED CLEARLY SHOWING THAT THE ANCHOR HAS DISLODGED FROM THE PATIENT'S SHOULDER. PATIENT AGE AND DEMOGRAPHICS WERE NOT REPORTED. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE WITH THE ANCHOR PRIOR TO USE AND THERE WAS NO COMPLICATIONS REPORTED DURING THE IMPLANT PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN SOLICITED.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. IT WAS REPORTED TO PARCUS MEDICAL LLC THAT A 5.0 TITANIUM ANCHOR PULLED OUT OF THE PATIENTS SHOULDER POST-OPERATIVELY. AN X-RAY WAS PROVIDED CLEARLY SHOWING THAT THE ANCHOR HAS DISLODGED FROM THE PATIENT'S SHOULDER. PATIENT AGE AND DEMOGRAPHICS WERE NOT REPORTED. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE WITH THE ANCHOR PRIOR TO USE AND THERE WAS NO COMPLICATIONS REPORTED DURING THE IMPLANT PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN SOLICITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824925 | V-LOX SUTURE ANCHOR | SCREW, FIXATION, BONE; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | PARCUS MEDICAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |