MAUDE Adverse Event Report: LIFE SPINE PROLIFT; EXPANDABLE INTERBODY

Model Number L151-695

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The inserter was stuck to the implant when trying to remove after insertion.There was a 10 minute surgical delay.

Manufacturer Narrative

It appears that the inserter was stuck to the implant when trying to remove in after implantation.This caused a 10 minute delay.

• Brand Name: PROLIFT
• Type of Device: EXPANDABLE INTERBODY
• 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: 16087902
• MDR Text Key: 307575806
• Report Number: 3004499989-2022-00018
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837142254
• UDI-Public: 00190837142254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L151-695
• Device Catalogue Number: L151-695
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other