MAUDE Adverse Event Report: LIFE SPINE, INC. THE AVATAR SPINAL SYSTEM; PEDICLE SCREW SYSTEM

Model Number UNKNOWN

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/20/2016

Event Type  malfunction  

Event Description

Set screw shown to be disengaged from screw on x-ray.(7 months post operatively).

• Brand Name: THE AVATAR SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s quality dr; huntley IL 60140
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s quality dr; huntley IL 60142
• Manufacturer Contact: randy lewis ; 13951 s quality dr; huntley, IL 60142 ; 8478846117
• MDR Report Key: 5809983
• MDR Text Key: 50066762
• Report Number: 3004499989-2016-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

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: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: 148-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR