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	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant is still in transit and no additional information about the revision is available at this time; therefore, the reason for the revision surgery and whether it is related to the tops system could not be determined.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 submitted.
Event or Problem Description
The company received an explant from a clinic in the us.No information was provided regarding the reason for device removal.No other details were provided and no additional information is available at this time.
Additional Manufacturer Narrative
The explant was returned and a visual assessment identified signs of wear.Examination of the bottom plate arms and set screws indicated that the set screws were not fully tightened, which likely resulted in slippage of the bottom plate arms in the pedicle screws and subsequent implant misalignment.Based on the available information, it was concluded that the subsequent surgery was most likely related to the surgical technique employed during the original procedure rather than 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.
Event or Problem Description
The company received an explant from a clinic in the us.No information was provided regarding the reason for device removal.No other details were provided.The explant arrived for investigation and was examined.

• 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: 23486405
• Report Number: 3012401682-2025-00013
• Device Sequence Number: 21464344
• 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: 2025
• 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,Followup
• Report Date (Section B): 01/20/2026

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 Lot Number: RTU0791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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 Sex: Unknown