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

Model Number	T080-0042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that an irix-a inserter broke, the breakage was noticed following a case, there were no known patient complications.The complainant stated that two irix-a inserters were set up during the surgery and only one was used.It is unknown if the broken inserter was used during the surgery.The inserter that was used, functioned as intended during the case and the surgery proceeded as normal.Visual assessment of the returned inserter showed an instrument with repeated use.The tab of the implant inserter drawbar was fractured proximal to where the tab is located.It is unknown how the inserter was damaged.It may be possible that overtightening the inserter/inserter tip or incorrectly loading the inserter tip could contribute t the inserter malfunction.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being made available for distribution.
Event or Problem Description
The complainant reported that an irix-a inserter broke, the breakage was noticed following a case, there were no known patient complications.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8262905
• Report Number: 3005031160-2019-00005
• Device Sequence Number: 11313489
• Product Code: OVD
• UDI-Device Identifier: M697T08000421
• UDI-Public: M697T08000421
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: T080-0042
• Device Lot Number: 045211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• 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