MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. FORTILINK-C IBF SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	65-C-INSERTER
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 11/15/2024.It was reported that the proximal portion of a system inserter handle separated from the body of the instrument while being used.There were no known patient complications associated with this complaint, the surgical procedure was successfully completed by placing the system implant with an alternate available instrument.An rma# was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 12/11/2024.
Additional Manufacturer Narrative
A visual assessment of the returned system inserter showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The proximal portion of the instrument handle was partially unthreaded from the instrument body as reported.A functionality assessment determined the proximal portion of the instrument handle rotated independently of the attached handle component.The proximal portion of the handle is intended to be epoxied and retained within the instrument body.A dhr review was performed for the system inserter lot and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 2/08/2018.It may be possible for the proximal portion of the system inserter handle to be separated from the instrument body if the component was unthreaded.The handle component could be unthreaded from the body of the instrument if the adhesive used did not maintain adhesion.There appeared to be remnants of adhesive present on the threading of the separated instrument components.The root cause of this complaint is the adhesive used to connect the inserter components did not maintain adhesion as intended.There have not been any other complaints of similar nature for the system inserter with separated components.The manufacturer will continue to monitor for reports of non-functional instruments and perform complaint investigations as appropriate.

• Brand Name: FORTILINK-C IBF SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 20920167
• Report Number: 3005031160-2024-00041
• Device Sequence Number: 5092975
• Product Code: ODP
• UDI-Device Identifier: 00846468080228
• UDI-Public: 00846468080228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 65-C-INSERTER
• Device Lot Number: 304900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown