INVICTUS OCT SPINAL FIXATION SYSTEM
Received Jun 15, 2026 · Event occurred May 19, 2026
Report 2027467-2026-00115 · MDR key 25506183
Device
Generic name
Posterior Cervical Screw System
Manufacturer
Alphatec Spine, Inc.Model number
18100Catalog number
18100
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE IMPLANTS REMAIN IN SITU AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. THE AFFECTED LOT NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE, INC. IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA REGULATIONS UNDER 21 CFR 803. ALL RELEVANT AND AVAILABLE INFORMATION HAS BEEN INCLUDED TO THE BEST OF OUR KNOWLEDGE AT THE TIME OF THIS SUBMISSION. ANY FIELDS LEFT BLANK REFLECT INFORMATION THAT WAS NOT KNOWN OR NOT PROVIDED. SHOULD ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
FOLLOWING A POSTERIOR CERVICAL FUSION PROCEDURE, RADIOGRAPHIC IMAGING OBTAINED AT THE THREE-MONTH POSTOPERATIVE VISIT REVEALED DISENGAGEMENT OF A SET SCREW FROM THE TULIP, RESULTING IN ROD SLIPPAGE. THIS IS REPORT 1 OF 2.