AFT ALLOGRAFT FILLER TUBE
Received Oct 7, 2025 · Event occurred Aug 25, 2025
Report 2135156-2025-00008 · MDR key 23235514
Device
Generic name
Resorbable Calcium Salt Bone Void Filler
Manufacturer
Spineology Inc.Catalog number
227005
Lot number
T24229
Product problems
- Improper or Incorrect Procedure or Method
- Unintended Movement
- Improper or Incorrect Procedure or Method
- Unintended Movement
Patient
NA · Unknown
- Pain
- Pain
Narrative
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 BONE GRAFT OUTSIDE OF THE DISC SPACE; HOWEVER, THE SURGEON OPTED TO LEAVE THE DEVICE AS IMPLANTED AS THE PATIENT WAS NOT EXPERIENCING ANY ADVERSE SYMPTOMS. APPROXIMATELY SIX (6) WEEKS LATER, THE PATIENT RETURNED WITH SYMPTOMS AND A REVISION SURGERY WAS CONDUCTED TO REMOVE EXPELLED BONE GRAFT MATERIAL. THE PATIENT SYMPTOMS HAVE REPORTEDLY IMPROVED FOLLOWING THE REVISION SURGICAL PROCEDURE.
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. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.