MAUDE Adverse Event Report: LIFE SPINE PROLIFT LATERAL; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	58-1855-0708
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was not returned to life spine and there is no additional information on the failure; therefore, it is not possible to determine what was the root cause of the prolift lateral expandbale spacer implant migration as was reported.
Event or Problem Description
It was reported that "l3-4 prolift lateral cage migration", "post-operatively", and "still in patient, revision surgery planned.".

• Brand Name: PROLIFT LATERAL
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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
• MDR Report Key: 16863849
• Report Number: 3004499989-2023-00007
• Device Sequence Number: 17489187
• Product Code: MAX
• UDI-Device Identifier: 00190837085469
• UDI-Public: (01)00190837085469
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/03/2023

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: 58-1855-0708
• Device Catalogue Number: 58-1855-0708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female