MAUDE Adverse Event Report: XTANT MEDICAL IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned awl showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip of the awl was fractured as reported, and the tip was dull with rotational scratches present.A functionality assessment could not be performed due to the damaged condition of the returned complaint instrument, which was removed from distributable inventory.A dhr review was performed for the returned complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 3/19/2014.The distal tip of a system awl could fracture if it was shifted laterally while being used.If the awl was inadvertently shifted laterally while the distal tip maintained a fixed position, it can result in the tip fracturing as identified on the complaint instrument.There have not been any other complaints of similar nature received in the past 12 months.The company will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The company received notification on (b)(6) 2021 for an instrument malfunction that occurred during an acdf procedure on (b)(6) 2021.The complainant reported that while preparing to implant a removed system screw, the distal tip of a system awl fractured.There were no deficiencies identified with the system implant or screw.The screw was removed because the neuromonitoring machine identified a loss in mep signals and the surgeon wanted to confirm that there was no obstruction to the spinal cord.There were no known patient complications or delay in treatment associated with this complaint investigation.This report is associated with mdr 3005031160-2021-00005.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11760704
• Report Number: 3005031160-2021-00006
• Device Sequence Number: 4492284
• Product Code: OVE
• UDI-Device Identifier: M697T06602001
• UDI-Public: M697T06602001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: T066-0200
• Device Lot Number: EM13M001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR