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

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the prolift inserter fractured while disengaging from a cage intra-operatively.
Additional Manufacturer Narrative
Device not returned it is hypothesized that during use an excessive force was applied to the installer at the angle which resulted in a torsional or off-ais asymmetric (rocking or toggle) load being applied to the distal tip of the installer.An expandable spacer installers are not designed to withstand an excessive torsional or off-axis load, an insertion forces applied at an angle may have resulted in the failure at the distal tip of the installer.

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 13309641
• Report Number: 3004499989-2022-00001
• Device Sequence Number: 5028758
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW20101
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: L151-596
• Device Catalogue Number: L151-596
• Device Lot Number: CNW2010
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown