AFT ALLOGRAFT FILLER TUBE
Received May 19, 2026 · Event occurred Apr 16, 2026
Report 2135156-2026-00002 · MDR key 25217539
Device
Generic name
Resorbable Calcium Salt Bone Void Filler
Manufacturer
Spineology Inc.Catalog number
227005
Lot number
T24420
Product problems
- Unintended Movement
Patient
50 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.
Description of Event or Problem
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AFT ALLOGRAFT FILLER TUBE AND IMMEDIATE POST-OPERATIVE IMAGING DISPLAYED POTENTIAL BONE GRAFT ANTERIOR TO THE IMPLANT. THE SURGEON ELECTED TO LEAVE THE DEVICE AS PLACED AND MONITOR THE PATIENT WITH NO PLANS FOR ANY MEDICAL INTERVENTION.