MAUDE Adverse Event Report: LIFE SPINE, INC. PROLIFT; EXPANDABLE INTERBODY

Model Number	58-1228-0710D
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It appears that the screws didn't provide fixation as required by the prolift product indications which allowed the implant to migrate.
Event or Problem Description
It was reported that the cage migrated posteriorly into the canal and had to be unexpanded, then removed.The screws were loose and to be replaced 8.5mm screws.

• Brand Name: PROLIFT
• Common Device Name: EXPANDABLE INTERBODY
• 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: 15928977
• Report Number: 3004499989-2022-00013
• Device Sequence Number: 17823295
• Product Code: MAX
• UDI-Device Identifier: 00190837021580
• UDI-Public: 00190837021580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 11/28/2022

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 Expiration Date: 03/13/2023
• Device Model Number: 58-1228-0710D
• Device Catalogue Number: 58-1228-0710D
• Device Lot Number: AX0439
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• 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: Other
• Patient Age: 53 YR
• Patient Sex: Male