Lateral Patient Positioning System 181-100Recalls & reported problems

Alphatec Spine, Inc. · Thoracic Positioner · Class 1

Data updated Oct 18, 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 00190376484112), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Patient Device Interaction Problem1

Patient problems

Bruise/Contusion1

Recent adverse event reports

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

InjuryApr 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
POSTOPERATIVELY, INTERNAL BLEEDING WAS NOTED UNDER THE PATIENT'S RIGHT AXILLA. THE ATTENDING NURSE CONFIRMED THAT THERE WAS NO EVIDENCE OF THIS BLEEDING PRIOR TO THE OPERATION AND INDICATED THAT IT WAS MOST LIKELY ASSOCIATED WITH THE USE OF THE POSITIONER. FOLLOWING THE SURGERY, THE PATIENT REPORTED NO PAIN RELATED TO THIS INCIDENT.
Patient problems: Bruise/Contusion
MAUDE report 21894986 ↗

Device details

UDI-DI	`00190376484112`
Brand	Lateral Patient Positioning System
Model	181-100
Company	Alphatec Spine, Inc.
Product code	CCX · SUPPORT, PATIENT POSITION
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	Jun 15, 2023

Device type (GMDN): Spinal surgery positioning board

A device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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