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

Model Number	151-261
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant and installer were sent back to life spine, both were investigated and there are no issues with either the implant or installer.
Event or Problem Description
Surgeon placed the implant and removed the installer, took an x-ray and determined that the implant needed to be moved.However could not attach the installer to the implant after attempts both visually and with a microscope determined that he could not re-attach.A vascular surgeon was called to remove the implant (removal process took 2-hours) , a new implant was installed and surgery was successful.

• Brand Name: LIFE SPINE
• Common Device Name: PROLIFT
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• MDR Report Key: 8623665
• Report Number: 3004499989-2019-00004
• Device Sequence Number: 19358676
• Product Code: MAX
• UDI-Device Identifier: 00190837030940
• UDI-Public: (01)00190837030940
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: 151-261
• Device Catalogue Number: 151-216
• Device Lot Number: CNW18061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/20/2019
• 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