MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 the company received a communication from a distributor that a crack was identified on an instrument.It was reported that during a surgical procedure on (b)(6) 2020 the complainant noticed that the instrument was not holding the implant well and identified the crack.It is unknown how the crack propagated on the instrument.There were no known patient complications associated with this complaint.The procedure was successfully completed using a general hospital instrument.A visual assessment of the returned complaint device showed an instrument with repeated use, as identified by surface scratches and worn laser markings.There was a crack on one of the forceps, distal to the instrument pivot point.A functionality assessment was not performed due to the damaged condition of the complaint instrument.The complaint investigation suggests the possibility that excessive force applied to the instrument handles may have contributed to the instrument malfunction.
Event or Problem Description
On (b)(6) 2020 the company received a communication from a distributor that a crack was identified on an instrument.It was reported that during a surgical procedure on (b)(6) 2020 the complainant noticed that the instrument was not holding the implant well and identified the crack.It is unknown how the crack propagated on the instrument.There were no known patient complications associated with this complaint.The procedure was successfully completed using a general hospital instrument.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 9924463
• Report Number: 3005031160-2020-00010
• Device Sequence Number: 3296750
• Product Code: OVE
• UDI-Device Identifier: M697T06600451
• UDI-Public: M697T06600451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: T066-0045
• Device Lot Number: 14604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR