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

Model Number	85859
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	01/20/2026
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 device failure was indicated in the original procedure or in the explanted implants at the time of revision.The explanted screws were not returned for investigation.An incidental dural tear (idt) is a relatively common complication during spinal surgery.Many factors influencing the incidence of idt have been reported in the literature, including surgical complexity, surgeon's experience and patient factors, such as older age, sex, primary disease, and previous surgery.Pedicle screw loosening is a known complication of spinal fusion and orthopedic fixation procedures.Screw loosening may be attributed to multiple factors including bone quality, patient's age and weight bearing forces as well as surgical technique.The rate of dural tears and screw loosening associated with premia spine procedures remains below the rates reported in the published literature for spine fusion procedures.Dural tears are typically identified and repaired intraoperatively or during the immediate post-operative period.It is uncommon for dural tears to be first identified two months following surgery.In contrast, pedicle screw loosening is generally a progressive process that develops over time.Two attempts were made to contact the surgeon to obtain additional clinical information regarding the screw loosening and the durotomy in order to further assess the event.As of the date of this report, no response has been received.Should further relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The company was informed of a revision case of the tops system in the us approximately two months post-implantation.The procedure involved a durotomy repair and the removal of a pain pump.Intraoperatively, two 6.5x50mm pedicle screws at l5 were identified as loose; these were explanted and replaced with 7.5x50mm screws.Additionally, two l4 set screws were replaced and the tops implant was subsequently reimplanted.

• Brand Name: TOPS SYSTEM
• Common Device Name: MOTION-PRESERVING SPINAL IMPLANT
• Manufacturer (Section D): PREMIA SPINE LTD; giborey israel 7; ramat poleg, netanya central,; 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 ; giborey israel 7; ramat poleg, netanya central, il 4250407; netanya, 42504-07 ; IS 4250407
• MDR Report Key: 24404829
• Report Number: 3012401682-2026-00002
• Device Sequence Number: 20875022
• Product Code: QWK
• UDI-Device Identifier: 07290014064041
• UDI-Public: 07290014064041
• 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): 02/20/2026

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: 85859
• Device Lot Number: RTU0841
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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 Age: 57 YR
• Patient Sex: Male