MAUDE Adverse Event Report: LIFE SPINE PROLIFT

Model Number	58-1228-0708
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is believed that the surgeon did not expand the device so that the endplates were secure or surgeon used incorrect sized implant.
Event or Problem Description
It was reported that an implant that was implanted on (b)(6) 2019 had migrated/moved forward in position and needed to be removed.

• Brand Name: PROLIFT
• Common Device Name: PROLIFT
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley, il
• MDR Report Key: 10180912
• Report Number: 3004499989-2020-00004
• Device Sequence Number: 2560708
• Product Code: MAX
• UDI-Device Identifier: 00190837019020
• UDI-Public: 00190837019020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 58-1228-0708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/22/2020
• 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