MAUDE Adverse Event Report: LIFE SPINE PROLIFT; EXPANDABLE INNERBODY

Model Number	58-1228-1508Z
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon review of xray images provided by user it was determined that the pedicle screw system (vitality system not life spine product) the set screws on the tulip heads were not locked down correctly this allowed the rods in the tulip heads to float freely, because the spine was not fixated as required with prolift this allowed the prolift interbody to migrate.
Event or Problem Description
Surgery had to be revised because prolift implant was backing out and found 5 loose set screws.

• Brand Name: PROLIFT
• Common Device Name: EXPANDABLE INNERBODY
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• MDR Report Key: 12284826
• Report Number: 3004499989-2021-00009
• Device Sequence Number: 3970891
• Product Code: MAX
• UDI-Device Identifier: 00190837079499
• UDI-Public: (01)00190837079499(17)221204(10)JC34
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 12/04/2022
• Device Model Number: 58-1228-1508Z
• Device Catalogue Number: 58-1228-1508Z
• Device Lot Number: JC34
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR