TOPS Inserter 82889Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290115932638), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Solder Joint Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Jul 16, 2025Class IIOpen, Classified
Potential for missing pins at tip of inserter.
Z-2516-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Device problems

Solder Joint Fracture1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 30, 2025Solder Joint Fracture; Solder Joint Fracture
UPON COMPLETION OF IMPLANTATION AND FINAL TIGHTENING OF THE TOPS SYSTEM, THE US SURGEON REMOVED THE TOPS INSERTER AND NOTICED A PIN THAT HAD BROKEN OFF THE INSERTER'S TIP. THE SURGEON REMOVED THE PIN AND CONTINUED TO FINAL SUTURING OF THE PATIENT WITH NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427252 ↗

Device details

UDI-DI	`07290115932638`
Brand	TOPS Inserter
Model	82889
Company	Premia Spine Ltd
Product code	QWK · Prosthesis, Posterior Spinal Elements
Class	Class 3
FDA submission	P220002
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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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 13, 2026 · each recall links to the FDA recall notice
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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