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

Model Number	82644
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records of the involved lot was performed and indicated that it was manufactured in accordance with specifications without deviations.At the time of the removal, the implants appeared well preserved, and there were no special implant-related observations.The explant was not received at the time of this report.Based on the information available to date, the event seems to be related to discogenic degeneration rather than to the tops system.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.If any additional relevant information becomes available, a supplemental report will be submitted as applicable.
Event or Problem Description
The company was informed about a revision case of the tops system in the us after more than 5 years.The original procedure was performed on (b)(6) 2020.The patient was treated with tops at l4-l5 as part of the us ide clinical study.The patient complained of an increase in back pain.Based on the pattern of pain, patient exam and imaging analysis, the surgeon suspected that the major pain generator is likely disc degeneration at the level of the tops device.In the revision surgery, the tops system was removed and fusion was performed.

• 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: 23413049
• Report Number: 3012401682-2025-00011
• Device Sequence Number: 10380924
• Product Code: QWK
• UDI-Device Identifier: 07290014064034
• UDI-Public: 07290014064034
• 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: 2020
• 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): 10/29/2025

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: 10/31/2022
• Device Model Number: 82644
• Device Lot Number: RTP0242US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2018
• 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