MAUDE Adverse Event Report: Premia Spine Ltd. TOPS System; Motion-preserving spinal implant

Model Number	TOPS 30M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The company was informed about a revision case of the tops system in the us after more than 5 years of implantation.The original procedure was performed on (b)(6), 2021.The patient was treated with tops at l4-l5 as part of the us ide clinical study.Patient experienced initial relief of pain symptoms after surgery but by month 3 the back pain had returned and remained until her completion of the clinical study.The device remained functional for the full duration.The tops system was removed as part of the revision surgery and fusion was performed.During the revision procedure, the surgeon noted that the patient's disc had degenerated and was not moving in flexion/extension.The surgeon had to convert to fusion because the patient was experiencing back pain.
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 without deviations.Explant was returned for investigation and examined.The explant analysis identified wear of the internal parts of the implant.Review of x-rays from implantation indicated malplacement of the patient on the operating table, segmental reduction, and a mispositioned tops implant which may have collectively contributed to wear.The rate of revisions for the tops system is lower than the reported rates in the literature for similar systems.

• 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: 50587191
• Report Number: 3012401682-2026-00009
• Device Sequence Number: 21358268
• 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: 2021
• 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): 09/03/2026

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: 10/31/2023
• Device Model Number: TOPS 30M
• Device Catalogue Number: 85859
• Device Lot Number: RTP0313US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• 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: 59 YR
• Patient Sex: Female