MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	L151-597
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two prolift inserters were broken during a tlif procedure.When the interbody portion of the procedure began, paddles were inserted on both sides up to 9 milimeters, which was deemed appropriate.8 mm expandable pro lift cages were selected.The first expandable cage (a) was inserted with no problems.When the contralateral cage (b) was inserted, a problem was observed on neuromonitoring.Both expandable cages were removed.During the first removal (a), the attached inserter was broken when the surgeon was manually pulling up on the cage and inserter to remove the cage.The broken piece went into the disc space.Cage b was then removed using the attached inserter and a slap hammer with no difficulty.The inserter was detached from cage b and was attempted to be attached to cage a for removal.The inserter broke during this process, and the cage was removed with alternative instrumentation, which took approximately 15 to 20 minutes.The broken piece of inserter was then removed from the disc space.A static cage was implanted in place of the expandable cages, and the case was concluded without executing the remainder of the surgical plan.Minor improvement was noted on neuromonitoring.Post operatively, the patient is experiencing a bilateral loss of sensation and motor control in the lower extremities, including a total lack of sensation in the feet.Level: l3, l4.Adverse consequences: bilateral loss of sensation and motor control in the lower extremities, including a total lack of sensation in the feet.
Event or Problem Description
It was stated "2 broken 8mm prolift inserters".

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 19619729
• Report Number: 3004499989-2024-00006
• Device Sequence Number: 6954935
• Product Code: MAX
• UDI-Device Identifier: 00190837137953
• UDI-Public: (01)00190837137953
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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 Model Number: L151-597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown