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

Model Number	70-1028-0915
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	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004499989-2023-00005
• Device Sequence Number: 6700362
• Product Code: MAX
• UDI-Device Identifier: 00190837107758
• UDI-Public: (01)00190837107758(17)251201(10)TMZ00076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: 12/01/2025
• Device Model Number: 70-1028-0915
• Device Catalogue Number: 70-1028-0915
• Device Lot Number: TMZ00076
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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