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

Model Number T066-0093

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant reported that a drill bit was broken while preparing a path to introduce the screw for the spacer.There were no reported patient complications.A visual assessment of the broke drill bit confirmed that the fluting of the drill bit was broken as described by the complainant.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to initial release to distribution.A drill bit could be broken if it had a lateral force applied.There are two techniques for implanting the associated implants.The technique that utilizes the straight drill also uses a guided inserter assembly.The guided inserter assembly has a hallow shaft to direct appropriate placement for screw hole preparation and screw insertion.If the drill was shifted while engaged within the guided inserter, it may break the drill bit.

Event Description

The complainant reported that a drill bit was broken while preparing a path to introduce the screw for the spacer.There were no reported patient complications.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 8761273
• MDR Text Key: 150261597
• Report Number: 3005031160-2019-00034
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: M697T06600931
• UDI-Public: M697T06600931
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T066-0093
• Device Lot Number: 45079-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 79