INVICTUS SPINAL FIXATION SYSTEM
Received Aug 20, 2025 · Event occurred Jul 25, 2025
Report 2027467-2025-00204 · MDR key 22853612
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Alphatec Spine, Inc.Model number
55203-075-045Catalog number
55203-075-045
Product problems
- Malposition of Device
- Malposition of Device
Patient
75 YR · Male
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
ABOUT 4 DAYS POSTOPERATIVELY, IT WAS REPORTED THAT THE SCREW HAD MEDIALLY BREACHED THE PEDICLE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE SCREW.
Additional Manufacturer Narrative
THE SCREW HAS NOT RETURNED FOR EVALUATION. RADIOGRAPHIC IMAGES WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.