MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSERTER

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were not returned to life spine therefore it is not possible to determine root cause.Based on the failure it is hypothesized that the implant cage was not fully collapsed when the slap hammering process began.This would have caused the cage to resist explantation resulting in excessive forces being applied to the distal tangs of the inserters and eventually resulting the tangs breaking off the inserters.The implant should always be completely collapsed prior to explant.
Event or Problem Description
2 prolift inserters broke while trying to remove cage that was too anterior with slap hammer, no component left in patient.

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 1351 quality drie; huntley, IL 60142 ; 8478846117
• MDR Report Key: 20761342
• Report Number: 3004499989-2024-00013
• Device Sequence Number: 18289422
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (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