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

Model Number	7265-40-55
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After inventory was received back from the distributor it was identified that there was a locking cap returned that wasn't a life spine product and it is believed that caused the issue of cold fusion.It is unknown why the screws were placed not optimal for the surgeon as the driver was not returned but the taps were and they dont have an signs of issue.
Event or Problem Description
Screws were not placed in a position optimal to physician, one tower broke at the designated area to soon due to too much force on rod and cap.Cap cold welded to driver.System was removed and replaced with a different system.

• Brand Name: AVATAR
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• MDR Report Key: 11254145
• Report Number: 3004499989-2021-00001
• Device Sequence Number: 19702318
• Product Code: MNH
• UDI-Device Identifier: 00190837001155
• UDI-Public: 00190837001155
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 7265-40-55
• Device Catalogue Number: 7265-40-55
• Device Lot Number: IU09
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR