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

Model Number	58-0832-0813M
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004499989-2023-00020
• Device Sequence Number: 2982952
• Product Code: MAX
• UDI-Device Identifier: 00190837141684
• UDI-Public: (01)00190837141684(17)260608(10)JZ61
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: D453301K2125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 10/16/2023

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 Expiration Date: 06/08/2026
• Device Model Number: 58-0832-0813M
• Device Lot Number: JZ61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male