TOPS™ - 21 L 82643Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290014064003), received between Oct 30, 2023 and May 13, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
- Material Split, Cut or Torn1
- Noise, Audible1
Patient problems
- Pain4
- Implant Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Noise, Audible
THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN ISRAEL. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TOPS SYSTEM WITH VERSALINK ON (B)(6), 2015 AND HAD 3 REVISIONS SINCE TO REPLACE THE IMPLANTS WHILE THE PEDICLE SCREWS REMAINED IN-SITU. THE PATIENT RECENTLY COMPLAINED OF PAIN AND NOISE DURING MOVEMENT, AND ON (B)(6) 2026, THE TOPS IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE AS PART OF AN ADDITIONAL REVISION SURGERY, AFTER PATIENT WAS DIAGNOSED WITH DEGENERATED DISC AT L3-4, AND SPINAL STENOSIS AT L2-3.
Patient problems: Pain
MAUDE report 25163791 ↗InjuryFeb 13, 2026Loose or Intermittent Connection
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.
Patient problems: Pain
MAUDE report 24332227 ↗InjuryApr 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM IN ISRAEL. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO SPINAL STENOSIS WITH GRADE I SPONDYLOLISTHESIS. THE PATIENT WAS TREATED WITH TOPS AT L4-L5. THE PATIENT RECENTLY COMPLAINED OF PAIN AND NOISES FROM THE BACK DURING MOVEMENT, AND ON (B)(6) 2025, THE TOPS MOTION IMPLANT WAS REMOVED AND REPLACED WITH A NEW TOPS DEVICE AS PART OF THE REVISION SURGERY. THE TOPS EXPLANT WAS RETURNED FOR INVESTIGATION.
Patient problems: Implant Pain
MAUDE report 21750031 ↗InjuryJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
THE COMPANY WAS INFORMED OF A REVISION CASE FOR THE TOPS SYSTEM IMPLANTED TOGETHER WITH VERSALINK IN GERMANY. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2021, DUE TO SPINAL STENOSIS AND DEGENERATIVE DISC DISEASE AT L5/S1. THE PATIENT WAS TREATED WITH DECOMPRESSION AND TOPS AT L4/L5, AND VERSALINK AT L5/S1. AFTER A FEW MONTHS, THE PATIENT COMPLAINED OF PAIN. IN THE REVISION SURGERY, WHICH WAS PERFORMED AFTER MORE THAN 2 YEARS, THE TOPS MOTION IMPLANT AND VERSALINK RODS WERE REPLACED WITH TWO-LEVEL FUSION RODS. THE ORIGINAL SCREWS WERE WELL FIXED IN THE PEDICLES AND REMAINED IN-SITU. THE EXPLANTS HAVE NOT BEEN RETURNED FOR INVESTIGATION.
Patient problems: Pain
MAUDE report 18534168 ↗InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM IN ISRAEL. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO L3-L4 AND L4-L5 SPINAL STENOSIS. THE PATIENT WAS TREATED WITH TOPS AT L4-L5 AND A LAMINECTOMY AT L3-L4. AT SOME POINT AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF UNRESOLVED PAIN. AS PART OF THE REVISION SURGERY, WHICH WAS PERFORMED AFTER MORE THAN 4 YEARS, THE TOPS MOTION IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED L3-L5. ACCORDING TO THE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE REASON FOR THE PAIN WAS THE INSTABILITY OF LEVEL L3-L4 DUE TO A WIDE LAMINECTOMY. NEITHER THE TOPS DEVICE NOR THE L4-L5 SEGMENT WERE THE PROBLEM. ALL SCREWS WERE FIRMLY FIXED AND USED FOR THE FUSION PROCEDURE. THE TOPS EXPLANT WAS RETURNED FOR INVESTIGATION.
Patient problems: Pain
MAUDE report 18028765 ↗
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™ - 30 M 85859Premia Spine Ltd · Prosthesis, Posterior Spinal Elements4 reports
- TOPS™ - 30 L 82644Premia Spine Ltd · Prosthesis, Posterior Spinal Elements2 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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