TX IBF SYSTEM
Received Aug 15, 2024 · Event occurred Aug 8, 2024
Report 3004719693-2024-00001 · MDR key 19996683
Device
Generic name
Intervertebral Fusion Device With Bone Graft
Manufacturer
Innovasis, Inc.Model number
LS-397-0705Catalog number
LS-397-0705
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING SURGERY, A TX TRIAL LS-397 BROKE OFF OF THE INSERTER LS-395. THE TRIAL WAS LEFT IMPLANTED IN THE PATIENT INSTEAD OF BEING REPLACED WITH THE INTENDED CAGE, AND GRAFT WAS PACKED AROUND IT. THE SURGEON DID NOT WANT TO TRY AND REMOVE THE STUCK TRIAL.
Additional Manufacturer Narrative
PER SYSTEM DFMEA THE FOLLOWING LINE ITEMS MAY APPLY: "INSTRUMENT BREAKAGE/DAMAGE" MAY LEAD TO "CUSTOMER DISSATISFACTION, SURGICAL DELAY" "TRIAL IMPLANTED" MAY LEAD TO "FAILED FUSION, IMPLANT MIGRATION, PAIN, SURGICAL DELAY, REVISION SURGERY." FOR THIS SPECIFIC CASE, THE ONLY EFFECT ON THE PATIENT THUS FAR HAS BEEN SURGICAL DELAY. IMPLANTING THE TRIAL IMPLANT IS CONSIDERED OFF-LABEL USE THEREFORE THE CUSTOMER IS ADVISED TO MONITOR FOR ANY ADVERSE EFFECTS.
Remedial action
- Patient Monitoring