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

Model Number	82643
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No failure was indicated in the original procedure or in the explanted implants at the time of revision.Explants were not returned for investigation.Screw loosening is a known complication of spinal fusion and orthopedic fixation procedures, which may be attributed to multiple factors including bone quality, patient's age and weight bearing forces as well as surgical technique.The rate of screw loosening associated with premia spine procedures is much lower than the rates reported in the published literature for spine fusion procedures.
Event or Problem Description
Patient implanted with the tops system in germany, underwent a revision surgery due to screw loosening after more than 2 years.The original surgery was performed on (b)(6) 2023, tops system was implanted at l4-l5.On (b)(6) 2026, the tops system was removed in a revision surgery.During the surgery it was found that the superior (l4) screws were loose.All the implants were removed without issue and a conversion to fusion (tlif + cement augmented pedicle screws) was performed.

• 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: 24332227
• Report Number: 3012401682-2026-00001
• Device Sequence Number: 13207068
• Product Code: QWK
• UDI-Device Identifier: 07290014064003
• UDI-Public: 07290014064003
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/13/2026

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 Expiration Date: 06/30/2026
• Device Model Number: 82643
• Device Lot Number: RTP0515
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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: 59 YR
• Patient Sex: Female