TOPS™ - 30 M 85859Recalls & 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: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290014064041), received between Jan 4, 2024 and Sep 3, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Loose or Intermittent Connection1
Naturally Worn1
Use of Device Problem1

Patient problems

Insufficient Information2
Dural Tear1
Pain1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjurySep 3, 2026Use of Device Problem
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.
Patient problems: Pain
MAUDE report 50587191 ↗
InjuryFeb 20, 2026Loose or Intermittent Connection
THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM IN THE US APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE PROCEDURE INVOLVED A DUROTOMY REPAIR AND THE REMOVAL OF A PAIN PUMP. INTRAOPERATIVELY, TWO 6.5X50MM PEDICLE SCREWS AT L5 WERE IDENTIFIED AS LOOSE; THESE WERE EXPLANTED AND REPLACED WITH 7.5X50MM SCREWS. ADDITIONALLY, TWO L4 SET SCREWS WERE REPLACED AND THE TOPS IMPLANT WAS SUBSEQUENTLY REIMPLANTED.
Patient problems: Dural Tear
MAUDE report 24404829 ↗
InjuryJun 22, 2025Naturally Worn; Naturally Worn
THE COMPANY WAS INFORMED OF A REVISION CASE OF THE TOPS SYSTEM WITH VERSALINK IN THE UK. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. ON (B)(6) 2025, THE TOPS MOTION IMPLANT AND VERSALINK RODS WERE REMOVED AND REPLACED WITH NEW IMPLANTS IN A REVISION SURGERY. THE EXPLANTS WERE NOT RETURNED FOR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 22304616 ↗
InjuryJan 4, 2024Adverse 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 FRANCE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2022. IN THE REVISION SURGERY, WHICH WAS PERFORMED AFTER MORE THAN A YEAR, THE TOPS MOTION IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE. NO OTHER DETAILS WERE PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18441900 ↗

Device details

UDI-DI	`07290014064041`
Brand	TOPS™ - 30 M
Model	85859
Company	Premia Spine Ltd
Product code	QWK · Prosthesis, Posterior Spinal Elements
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Nov 9, 2023

Device type (GMDN): Posterior lumbar spine prosthesis

A sterile implantable device designed to replace anatomical structures removed from the posterior aspect of lumbar vertebrae (i.e., the lamina, facet joint, and bony elements) during spinal decompression surgery to provide stability to, and enable normal range of motion of, the lumbar spine. It consists of a two-plate unit positioned in the posterior midline, which connects horizontal rods that are attached laterally to adjacent vertebrae with pedicle screws; the plates include interlocking trunnions for rotational/angular motion. The device may be a single unit or modular assembled during implantation. Dedicated tools for implantation are included.

Other Prosthesis, Posterior Spinal Elements devices

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All Prosthesis, Posterior Spinal Elements devices →

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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