MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE; AVATAR

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

The patient appears to have weak osteoporotic bone, the pedicle fractured as a result of excessive stressed applied to the weak bone.

Event Description

It was reported, "during surgery, potentially during final tightening/tab removal portion of the case, one of the patient's pedicles/transverse processes fractured.This resulted in removal of that side of the construct.

• Brand Name: LIFE SPINE
• Type of Device: AVATAR
• Manufacturer (Section D): LIFE SPINE; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 s. quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 8412433
• MDR Text Key: 138568898
• Report Number: 3004499989-2019-00001
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR