TOPS™ - 30 L 82644Recalls & reported problems
Premia Spine Ltd · The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression. · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290014064034), received between Oct 29, 2025 and Nov 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Noise, Audible” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Noise, Audible1
Patient problems
- Inadequate Pain Relief1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Noise, Audible; Noise, Audible
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.
Patient problems: Pain
MAUDE report 23657039 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN THE US AFTER MORE THAN 5 YEARS. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS TREATED WITH TOPS AT L4-L5 AS PART OF THE US IDE CLINICAL STUDY. THE PATIENT COMPLAINED OF AN INCREASE IN BACK PAIN. BASED ON THE PATTERN OF PAIN, PATIENT EXAM AND IMAGING ANALYSIS, THE SURGEON SUSPECTED THAT THE MAJOR PAIN GENERATOR IS LIKELY DISC DEGENERATION AT THE LEVEL OF THE TOPS DEVICE. IN THE REVISION SURGERY, THE TOPS SYSTEM WAS REMOVED AND FUSION WAS PERFORMED.
Patient problems: Inadequate Pain Relief
MAUDE report 23413049 ↗
Other Prosthesis, Posterior Spinal Elements devices
- TOPS Inserter 82889Premia Spine Ltd · Prosthesis, Posterior Spinal Elements1 recall1 report
- TOPS™ - 21 M 85858Premia Spine Ltd · Prosthesis, Posterior Spinal Elements8 reports
- TOPS™ - 21 L 82643Premia Spine Ltd · Prosthesis, Posterior Spinal Elements5 reports
- TOPS™ - 30 M 85859Premia Spine Ltd · Prosthesis, Posterior Spinal Elements4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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