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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Installer was not returned, based on the potential failure per given description of the issue, it is hypothesized that during excessive force was applied to the installe at an angle which reulted in a torsional or off-axis asymmetric (rocking or toggling) load being applied to the distal tip of the installer.
Event or Problem Description
Installer broke off during surgery, a piece was left in the patient but surgeon was able to retrieve the broken portion.

• 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: 15262619
• Report Number: 3004499989-2022-00009
• Device Sequence Number: 17551267
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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