IDYS ALIF
Received Jun 1, 2019 · Event occurred Mar 1, 2019
Report 3009962553-2019-00001 · MDR key 8661195
Device
Generic name
Lumbar Intervertebral Body Fusion
Manufacturer
Clariance SasModel number
24430018-SCatalog number
24430018-S
Lot number
I752C-IA10Y
Product problems
- Break
- Break
Patient
61 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IN THE ABSENCE OF THE PRODUCT, CLARIANCE CAN NOT GO AHEAD IN ITS INVESTIGATION. THE EXACT REASONS FOR THIS INCIDENT REMAIN UNDETERMINED. HOWEVER CLARIANCE SUSPECTS THAT A BAD INSERTION OF THE SCREW IS THE CAUSE OF THIS ISSUE. INDEED A SIMILAR CASE HAPPENED IN (B)(6) AND FOR WHICH A CORRECTIVE ACTION WAS PUT IN PLACE. INDEED, A TIPS AND TRICKS WAS MADE TO EXPLAIN HOW TO INSERT THE SCREW IN THE PLATE WITHOUT EXPLODING THE SLEEVE.
Description of Event or Problem
IT WAS REPORTED TO US THAT DURING IDYS ALIF SURGERY IN LEVEL L4-L5, UPON FINAL TIGHTENING OF THE SCREW, THE SLEEVE CAME OUT OF THE PLATE. THE SLEEVE WAS RETRIEVED AND DISPOSED BY THE SURGEON . AS A CONSEQUENCE, 3 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WERE INSERTED POSTERIORLY.
Remedial action
- Patient Monitoring
- Other