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

Model Number	L151-596
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prolift inserter tips broke while attached to the cage in the disc space.
Additional Manufacturer Narrative
It appears that the implant wasn't closed completely and the installer twisted causing failure.

• 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: 13541990
• Report Number: 3004499989-2022-00003
• Device Sequence Number: 4299296
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610
• 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): 02/15/2022

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: L151-596
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 42 YR
• Patient Sex: Female