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

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was stated, "prolift expandable inserter broken tongs at distal tip.Interbody looked crooked under x-ray imaging.Prolift expandable cage still performed as intended.Unknown when tongs of inserter were broken.Bottom of inserter tongs still remained attached to inserter; component left in patient: unknown.Procedure was successfully completed.Cage was still able to be inserted and expanded to standards.The component that was left potentially in patient was a piece of the inserter prong.".
Additional Manufacturer Narrative
Based on the reported event and the returned device, it is hypothesized that during use, an excessive force was applied to the installer, potentially resulting in a torsional or off-axis asymmetric load (e.G., rocking or toggling) being applied to the distal tip of the installer.As expandable spacer installers are not designed to withstand excessive torsional or off-axis loads, an insertion force applied at an angle could have caused failure at the distal tip.Additionally, impacting on the system while the driver was enged could have led to a bottomed-out interference that could have resulted in the tangs fracturing off.Additionally, details regarding the event were requested.The complainant's response was, "i will try to get hands on x rays if i have time sometime this week." no further information or documentation was provided following this response.Due to the limited information and documentation provided, it is not clear if the tangs of the inserter broke during surgery and were left in the patient's body.Therefore, this mdr is being submitted as a precaution.

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality dr; huntley, IL 60142 ; 8478886117
• MDR Report Key: 22177082
• Report Number: 3004499989-2025-00010
• Device Sequence Number: 7818158
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW20101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: L151-596
• Device Lot Number: CNW20101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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: Other
• Patient Sex: Unknown