Continuum PS-01-1812ARecalls & reported problems

Pressio, Inc · ACDF IMPLANT KIT - 18X12MM ANGLED · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850039803024), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

Migration1

Patient problems

Dysphagia/ Odynophagia1

Recent adverse event reports

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

InjuryOct 25, 2023Migration; Migration
THE PATIENT HAD A C3-C4 ANTERIOR FUSION PROCEDURE THAT INCLUDED THE USE OF AN 18MM ANGLED CONTINUUM IMPLANT WITH AN 8MM INTERBODY CAGE FILLED WITH AUTOGRAFT. TWO WEEKS POST OP IT WAS IDENTIFIED THAT THE INTERBODY CAGE AND CONTINUUM IMPLANT HAD MIGRATED FORWARD RESULTING IN THE NEED FOR A REOPERATION. ON THE X-RAY IMAGING, THE SURGEON OBSERVED THAT THE CONTINUUM IMPLANT WAS NOT FLUSH AGAINST THE INTERBODY CAGE WHICH COULD HAVE ALLOWED THE MIGRATION OF THE INTERBODY CAGE. THE PATIENT HAD A TERRIBLE COUGH DUE TO COVID POST OPERATIVELY WHICH COULD HAVE CONTRIBUTED TO THE MIGRATION OF THE INTERBODY CAGE.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 18007896 ↗

Device details

UDI-DI	`00850039803024`
Brand	Continuum
Model	PS-01-1812A
Company	Pressio, Inc
Product code	PHQ · Anterior Staple As Supplemental Fixation For Fusion
Class	Class 2
FDA submission	K200301
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 9, 2023

Device type (GMDN): Memory-alloy orthopaedic fixation plate

A non-sterile implantable device made of a shape memory alloy (SMA) [e.g., nickel-titanium alloy (Nitinol)] designed for the fixation of a bone fracture without the use of screws or wires or other holding devices. It typically consists of a cylindrical or conical plate with a pair or pairs of gripping arms to bridge and stabilize the fracture gap of a bone, e.g., long bones, rib and sternum, and shield the site from stress as the bone heals. Compression is achieved by the temperature-controlled properties of the SMA. It is available in a variety of sizes and is typically surgically removed after the healing process. It is a single-use device intended to be sterilized prior to use.

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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