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

Model Number	85858
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
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.No failure was indicated in the original procedure or in the explant at the time of revision.Explant was not returned for investigation.Two attempts were made to contact the surgeon to obtain additional clinical information regarding the revision surgery with no response.Based on the available information which indicated use of two pedicle screws and two 50mm fusion rods, it is believed that the reason for the revision surgery was adjacent level disease and that the reported case is not device related.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.If additional information becomes available, a supplemental report will be filed.
Event or Problem Description
The company was informed of a revision case for the tops system in the us.No information was provided regarding the original procedure.In the revision surgery, the tops motion implant was removed and patient was fused.The original screws remained in-situ.

• 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: 25536025
• Report Number: 3012401682-2026-00006
• Device Sequence Number: 18481376
• Product Code: QWK
• UDI-Device Identifier: 07290014064010
• UDI-Public: 7290014064010
• 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: 2025
• Device Explanted Year: 2026
• 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): 06/17/2026

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 Catalogue Number: TOPS 21M
• Device Lot Number: RTU0798
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 38 YR
• Patient Sex: Female