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

Model Number T066-0205

Device Problems Break (1069); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Perforation of Vessels (2135)

Event Date 01/19/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient (b)(6) underwent an anterior cervical discectomy and fusion at levels c4-5, c5-6 and c6-7.The surgeon (b)(6) was holding the awl inside the implant screw hole and began to tap on the handle (awl attached) with a mallet, when the tip of the awl broke off.The surgeon (b)(6) had indicated that the handle (awl attached) had slipped and punctured an adjacent vessel to where he was working.The surgeon used flo-seal and suture(s) to close the punctured vessel.The surgery was concluded without further incident.

Manufacturer Narrative

(b)(4).

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: kriss anderson ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 4638562
• MDR Text Key: 5759339
• Report Number: 3005031160-2015-00003
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: T066-0205
• Device Lot Number: EM13M002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR