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

Model Number 58-1855-0708

Device Problem Migration (4003)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 04/03/2023

Event Type  Injury  

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 Description

It was reported that "l3-4 prolift lateral cage migration", "post-operatively", and "still in patient, revision surgery planned.".

• Brand Name: PROLIFT LATERAL
• Type of Device: 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
• MDR Text Key: 314499542
• Report Number: 3004499989-2023-00007
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837085469
• UDI-Public: (01)00190837085469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female