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

Model Number	30L
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2025
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 without deviations.The explant was obtained and is awaiting investigation.Implant noise, that may be related to the articulating mechanism, has 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.A supplemental report will be submitted if additional relevant information becomes available upon completion of explant investigation.
Event or Problem Description
The company was informed about a revision case of the tops system in israel.The original procedure was performed on (b)(6) 2014 due to spinal stenosis with grade i spondylolisthesis.The patient was treated with tops at l4-l5.The patient had revision surgery on (b)(6) 2022 due to pain and instability discovered in the index level.The patient recently complained of pain and noise during movement, and on (b)(6) 2025, the tops motion implant was removed and replaced with a new tops device as part of a 2nd revision surgery.The tops explant was returned for investigation.
Event or Problem Description
The company was informed about a revision case of the tops system in israel.The original procedure was performed on (b)(6) 2014 due to spinal stenosis with grade i spondylolisthesis.The patient was treated with tops at l4-l5.The patient had revision surgery on (b)(6) 2022 due to pain and instability discovered in the index level.The patient recently complained of pain and noise during movement, and on (b)(6) 2025, the tops motion implant was removed and replaced with a new tops device as part of a 2nd revision surgery.The tops explant was returned for investigation.
Additional Manufacturer Narrative
The explant analysis identified wear of the implant's internal components.The root cause of the observed wear could not be conclusively determined.Revisions associated with signs of wear have been previously reported in a small number of cases without any sequelae.The cause for the revision surgery in such cases may be multifactorial, involving patient and procedure related factors.Thus, in the present case, it is presumed that a combination of factors, including patient anatomy, surgical technique, and a high level of physical activity may have contributed to the wear.

• 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: 23657039
• Report Number: 3012401682-2025-00014
• Device Sequence Number: 15966257
• Product Code: QWK
• UDI-Device Identifier: 07290014064034
• UDI-Public: 07290014064034
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P220002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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 Expiration Date: 07/31/2025
• Device Model Number: 30L
• Device Catalogue Number: 82644
• Device Lot Number: RTP0419
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2020
• 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: 63 YR
• Patient Sex: Male