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	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that during an acdf revision due to nonunion, a forceps implant inserter and a guided angled awl were broken.The initial surgery was reportedly a non-x-spine product.There were no reported patient complications associated with the instrument malfunctions.The following mdrs correspond to this event: 3005031160-2019-00043.The forceps implant inserter was assessed.The distal portion of an arm on the forceps implant inserter was broken from the instrument.It was reported that when the surgeon squeezed the handles of the forceps implant inserter closed, one of the tips broke off approximately 4cm back from the distal tip.It may be possible that excessive pressure applied to the handles of the device contributed to the instrument malfunction.The surgeon was removing a cervical cage that was not manufactured by the company when the forceps implant inserter was broken.The teeth on the top and bottom of the implant are intended to prevent implant migration.These teeth may have prevented normal removal of the implant, resulting in the use applying excessive pressure to the instrument handles.A dhr review was performed for the forceps implant inserter and the device met all required specifications prior to initially being released to distribution on 06/03/2015.
Event or Problem Description
The complainant reported that during an acdf revision due to nonunion, a forceps implant inserter and a guided angled awl were broken.The initial surgery was reportedly a non-x-spine product.There were no reported patient complications associated with the instrument malfunctions.The following mdrs correspond to this event: 3005031160-2019-00043.

• 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 59714
• MDR Report Key: 9088042
• Report Number: 3005031160-2019-00044
• Device Sequence Number: 14168784
• Product Code: OVE
• UDI-Device Identifier: M697T06600451
• UDI-Public: M697T06600451
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: T066-0045
• Device Lot Number: 13602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/19/2019
• 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