TRIO PLUS 48902015Recalls & reported problems

Stryker Corporation · SMALL OFFSET CONNECTOR · Class 2 · Implant

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540494160), received between Mar 9, 2016 and Nov 2, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

Adverse Event Without Identified Device or Use Problem1
Difficult to Remove1
Material Deformation1
Material Integrity Problem1

Patient problems

No Code Available2
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 2, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; THE PATIENT UNDERWENT REMOVING SURGERY ON (B)(6)2016. THE SURGEON REMOVED THE SCREW AND THE OFFSET CONNECTER. AFTER SURGERY, THE CONNECTER RING WAS REMAINING PATIENT BODY WHEN THE SURGEON CHECKED THE IMAGE. THEREFORE THE SURGEON IS MONITORING FOR THE PATIENT. (UPDATE (B)(6) 2016: THE REASON FOR THE REVISION SURGERY WAS REMOVAL OF THE IMPLANTS BECAUSE THE PATIENT FUSED.
Patient problems: No Code Available
MAUDE report 6072224 ↗
InjuryMar 9, 2016Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; DURING SURGERY, THE SURGEON USED THE SCREW AND CONNECTOR FOR TH12 VERTEBRAL BODY FRACTURE. THE SURGEON REMOVED THE CONNECTOR ADAPTER FROM OFFSET CONNECTOR OF TH12 (LEFT) AND L1. TO REMOVE THE CONNECTOR ADAPTER FROM OFFSET CONNECTOR OF TH12 (RIGHT), THE SURGEON TRIED TO LOOSEN NUT, BUT IT WAS NOT POSSIBLE TO LOOSEN NUT. THEREFORE, THE SURGEON TRIED TO LOOSEN THE OFFSET CONNECTOR OF L1 (LEFT) AND REMOVE THE ROD. HOWEVER, IT WAS NOT POSSIBLE TO LOOSEN THE SET SCREW OF OFFSET CONNECTOR. THE SURGEON USED THE ROD CUTTER. AND HE USED BRAND-NEW SCREW AND THE OFFSET CONNECTOR. OPERATION TIME WAS EXCEEDED FOR ABOUT 3 HOURS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5490417 ↗

Device details

UDI-DI	`04546540494160`
Brand	TRIO PLUS
Model	48902015
Company	Stryker Corporation
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease 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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