MAUDE Adverse Event Report: LIFE SPINE, INC. LIFE SPINE; AVATAR

Model Number 4550-075

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Inflammation (1932)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

It appears that patient had reaction to the implant, once explanted no futher issue.

Event Description

The screw and rods were explanted which went fine.The following day the doctor mentioned that he had noticed excessive dark tissue.Tissue was sent to the lab and returned "abundant grey granular tissue causing inflammation.Surgeon noticed wear on the rod.

• Brand Name: LIFE SPINE
• Type of Device: AVATAR
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley, il
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s. quality drive; huntley, il
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, il ; 8846117
• MDR Report Key: 10048251
• MDR Text Key: 194846557
• Report Number: 3004499989-2020-00002
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00019083700082
• UDI-Public: 0019083700082
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4550-075
• Device Lot Number: CTE9262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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