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

Model Number X080-332615-12PC-STR

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Event Description

Sterile irix-a implant returned in box by customer due to not having the red tamper evident seal tag on the box.

• Brand Name: IRIX-A LUMBAR 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: 6235209
• MDR Text Key: 64245858
• Report Number: 3005031160-2017-00107
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: M697X08033261512PCSTR1
• UDI-Public: +M697X08033261512PCSTR1/$$7055848$
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Expiration Date: 09/01/2021
• Device Model Number: X080-332615-12PC-STR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other