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

Model Number 58-0832-0813M

Device Problem Device Tipped Over (2589)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

The prolift micro expandable spacer system was unable to be returned to life spine, therefore, it is not possible to determine what was the complete failure mode resulting in the reported event.However, based on the description of the event it is hypothesized that the root cause of this failure was likely loosened set screw in the pedicle screw system (pedicle screw system not a lifespine product) leading to compromised spinal stability and therefore resulting in the flipping of the prolift micro expandable.

Event Description

It was reported that: " [we] were notified by the surgeon and distributor that the prolift micro flipped over.They think it was due to the set screw from another pedicle screw system that unattached.Therefore, creating an unstable construct.Revision surgery to be scheduled the week of sept 18th".

• Brand Name: PROLIFT MICRO
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley 60142 ; 8478846117
• MDR Report Key: 17942066
• MDR Text Key: 325757357
• Report Number: 3004499989-2023-00020
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837141684
• UDI-Public: (01)00190837141684(17)260608(10)JZ61
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D453301K2125
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 58-0832-0813M
• Device Lot Number: JZ61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male