MAUDE Adverse Event Report: PREMIA SPINE LTD. TOPS SYSTEM; MOTION-PRESERVING SPINAL IMPLANT

Model Number	85859
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lots was performed and indicated that they were manufactured in accordance with company specifications without deviations.It should be noted that the patient's weight was 150kg with a bmi above 40; this bmi is a contraindication of the tops system.The explants were not available for examination and no other information was obtained.Photos of the removed tops indicate wear.As in other orthopedic spine implants, a certain rate of failures that are related to patient anatomy, progress of degenerative disease, surgical technique and other relevant factors and/or their combination, are expected.The rate of revisions for the tops system with or without versalink is lower than the reported rates in the literature for similar systems.
Event or Problem Description
The company was informed of a revision case of the tops system with versalink in the uk.The original procedure was performed on (b)(6) 2021.On (b)(6) 2025, the tops motion implant and versalink rods were removed and replaced with new implants in a revision surgery.The explants were not returned for investigation.

• Brand Name: TOPS SYSTEM
• Common Device Name: MOTION-PRESERVING SPINAL IMPLANT
• Manufacturer (Section D): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer (Section G): PREMIA SPINE LTD.; 7 giborey israel st.; ramat poleg; netanya, 42504 07; IS 4250407
• Manufacturer Contact: elinor limor ; 7 giborey israel st.; ramat poleg; netanya, 42504-07 ; IS 4250407
• MDR Report Key: 22304616
• Report Number: 3012401682-2025-00005
• Device Sequence Number: 7918984
• Product Code: QWK
• UDI-Device Identifier: 07290014064041
• UDI-Public: 07290014064041
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2025

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: 05/31/2025
• Device Model Number: 85859
• Device Lot Number: RTP0404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male