MAUDE Adverse Event Report: INNOVASIS, INC. TX IBF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Model Number	LS-397-0705
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: TX IBF SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): INNOVASIS, INC.; 614 e. 3900 s.; salt lake city UT 84107 1902
• Manufacturer (Section G): INNOVASIS, INC.; 614 e. 3900 s.; salt lake city UT 84107 1902
• Manufacturer Contact: michael thomas ; 614 e. 3900 s.; salt lake city, UT 84107-1902 ; 8012612236
• MDR Report Key: 19996683
• Report Number: 3004719693-2024-00001
• Device Sequence Number: 7163902
• Product Code: MAX
• UDI-Device Identifier: M711LS39707050
• UDI-Public: M711LS39707050
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LS-397-0705
• Device Catalogue Number: LS-397-0705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown