SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 8X35
Received Apr 13, 2023 · Event occurred Mar 14, 2023
Report 3005180920-2023-00260 · MDR key 16732222
Device
Generic name
Spine Sacro Iliac Screw J
Manufacturer
Medacta International SaModel number
03.65.503Catalog number
03.65.503
Lot number
1821608
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION ADDED: BATCH REVIEW PERFORMED ON 19 APRIL 2023: LOT 1821608: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. DETAILS OF THE JOINT SCREW (REFERENCE, LOT, MANUFACTURER AND EXPIRATION DATE, PMA/510 (K) NUMBER, UDI NUMBER, BATCH ANALYSIS). CORRECTED DATA: DESCRIPTION UPDATED BY ADDING: DURING THE SCREW REMOVAL THE 3 SCREWS BROKE.
Description of Event or Problem
REVISION SURGERY AFTER ABOUT 3 YEARS DUE TO PAIN, THE SURGEON WANTED TO REMOVE THE 3 ILIAC SCREWS IN ORDER TO SOLVE THE PAIN ISSUE. DURING THE SCREW REMOVAL THE 3 SCREWS BROKE.
Additional Manufacturer Narrative
CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: THE OBJECT OF THIS REPORT, IN LOUR UNDERSTANDING, IS THE NECESSITY TO REMOVE 3 ILIAC SCREWS THREE YEARS AFTER LUMBO-SACRAL-ILIAC STABILIZATION BECAUSE OF PAIN. THERE IS NO HINT THAT SUCH PAIN COULD HAVE BEEN CAUSED BY DEFECTIVE DEVICES.
Description of Event or Problem
REVISION SURGERY AFTER ABOUT 3 YEARS DUE TO PAIN, THE SURGEON WANTED TO REMOVE THE 3 ILIAC SCREWS IN ORDER TO SOLVE THE PAIN ISSUE.