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

Model Number 70-1028-0915

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that the cage would not expand and the surgeon ended up having to take out the implant.They tried opening a second cage and the same issue occurred.The implant only expanded with extreme downward pressure.The ended up explanting the second one as well and going with a straight aleutian cage.There was a 60 min surgical delay.

Manufacturer Narrative

Without the device we are unable to determine true cause, but upon discussion it appears the implant was packed with graft prior to expansion which is not the correct method.

• Brand Name: PROLIFT WEDGE
• Type of Device: PROLIFT WEDGE 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: 16728312
• MDR Text Key: 313226040
• Report Number: 3004499989-2023-00005
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837107758
• UDI-Public: (01)00190837107758(17)251201(10)TMZ00076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203361
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-1028-0915
• Device Catalogue Number: 70-1028-0915
• Device Lot Number: TMZ00076
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other