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

Model Number	85858
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The company received an explanted device which was replaced in a revision case of the tops system in the us on (b)(6) 2025.The original procedure was performed on (b)(6) 2024.In the revision surgery, the tops motion implant was removed and replaced with a new tops device.The tops explant was returned for investigation.
Additional Manufacturer Narrative
Review of the manufacturing records of the involved lot was performed and indicated that it was manufactured in accordance with company specifications without deviations.The explant was returned and a visual assessment identified signs of wear.The x-ray imaging points to improper patient positioning on the operating table and malpositioning of the tops implant, resulting in accelerated wear.Based on the available information, it was concluded that the reason for the subsequent surgery was probably related to the surgical technique in the original surgery and not to the tops system.Revisions, associated with signs of wear, have been previously reported in a small number of cases where the implant was revised, without any sequelae.The cause for the revision surgery in such cases may be multifactorial, including patient and procedure related factors.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.

• 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: 22304521
• Report Number: 3012401682-2025-00004
• Device Sequence Number: 4389167
• Product Code: QWK
• UDI-Device Identifier: 07290014064010
• UDI-Public: 07290014064010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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 Model Number: 85858
• Device Lot Number: RTU0639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: 52 YR
• Patient Sex: Female