MAUDE Adverse Event Report: LIFE SPINE PROLIFT; EXPANDABLE SPACER INTERBODY

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip of prolift jaws sheered off during insertion.There was a dural tear injury.
Additional Manufacturer Narrative
The instrument was not returned to life spine; therefore, it is not possible to determine what was the root cause of the tip fracture as was reported.

• Brand Name: PROLIFT
• Common Device Name: EXPANDABLE SPACER INTERBODY
• 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: 16068482
• Report Number: 3004499989-2022-00015
• Device Sequence Number: 6187043
• 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

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
• Device Catalogue Number: L151-596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2022
• 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 Sex: Female