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

Model Number 58-1228-0710D

Device Problem Device Slipped (1584)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 11/09/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 304956397
• Report Number: 3004499989-2022-00013
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837021580
• UDI-Public: 00190837021580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173182
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Male