MAUDE Adverse Event Report: LIFE SPINE PROLIFT LATERAL; INSTALLER

Model Number 151-1715

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

It is likely that the applied force on the distal tangs during implant manipulation and disengaging the installers from the implant exceeded the mechanical properties of the clamp's distal tangs.

Event Description

Inserter broke causing 20 min delay in surgery.

• Brand Name: PROLIFT LATERAL
• Type of Device: INSTALLER
• 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: 18584823
• MDR Text Key: 333824885
• Report Number: 3004499989-2023-00022
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837147303
• UDI-Public: (01)00190837147303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193258
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 151-1715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other