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

Model Number	58-0832-0813M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is still implanted but it appears that the surgeon over retracted the disc space causing the nerve damage.
Event or Problem Description
It was reported that during retraction before implant insertion, the surgeon may have retracted the nerves too much.The patient suffered drop foot, permanent nerve damage.It was also repoted that the surgeon stated the damage was a result of our implant not being a true 8mm implant.

• Brand Name: PROLIFT
• Common Device Name: EXPANDABLE CAGE
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 16174321
• Report Number: 3004499989-2023-00001
• Device Sequence Number: 11428367
• Product Code: MAX
• UDI-Device Identifier: 00190837141684
• UDI-Public: (01)00190837141684(17)250411(10)JS64
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2023

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 Expiration Date: 04/11/2025
• Device Model Number: 58-0832-0813M
• Device Lot Number: JS64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female