MAUDE Adverse Event Report: LIFE SPINE PROLIFT; EXPANDABLE SPACER SYSTEM

Model Number	58-1028-1508Z
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was unable to expand after insertion.Removing and adding new cage took an extra 10 minutes with no impact to the patient.
Additional Manufacturer Narrative
Without the device being returned to life spine, we are unable to determine root cause.

• Brand Name: PROLIFT
• Common Device Name: EXPANDABLE SPACER SYSTEM
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 16362569
• Report Number: 3004499989-2023-00003
• Device Sequence Number: 7258522
• Product Code: MAX
• UDI-Device Identifier: 00190837079413
• UDI-Public: 00190837079413
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

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: 09/15/2025
• Device Model Number: 58-1028-1508Z
• Device Catalogue Number: 58-1028-1508Z
• Device Lot Number: JU58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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: Unknown