UNIPLATE 289711000Recalls & reported problems

Medos International Sàrl · UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM QUICK COUPLE HANDLE · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034224817), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

Break1

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.

MalfunctionFeb 9, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE QUICK COUPLE HNDL WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1)UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM QUICK COUPLE HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13501287 ↗

Device details

UDI-DI	`10705034224817`
Brand	UNIPLATE
Model	289711000
Company	Medos International Sàrl
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Class	Class 1
FDA submission	None listed
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	May 29, 2026

Device type (GMDN): Surgical instrument handle, non-torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

AML EXCEL 2001-42-000
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2,009 reports
NA 03.010.523
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Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,166 reports
N/A 9560524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
866 reports
INHANCE 6500-11-104
Depuy (Ireland) · Orthopedic manual surgical instrument
831 reports
INHANCE 6500-11-102
Depuy (Ireland) · Orthopedic manual surgical instrument
567 reports
R3 71364450
Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
N/A 9561524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
494 reports

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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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