OsseoScrew 53075-55Recalls & reported problems

Alphatec Spine, Inc. · OSSEOSCREW F TI POLYAXIAL 7.5 X 55MM · Class 2 · Implant

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 00844856049192), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Break1
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.

InjuryJan 5, 2021Break; Fracture
THE OUTER EXPANSION PORTION OFF THE OSSEOSCREW FRACTURED AND BROKE DURING IMPLANTATION AT THE RIGHT S1. THE DETACHED SECTION WAS REMOVED BY UTILIZING THE REMOVAL TOOL. THAT LOCATION WAS RE-INSTRUMENTED WITH AN ALTERNATIVE ATEC PRODUCT. THE EVENT CAUSE OVER A 30 MINUTE DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11117911 ↗

Device details

UDI-DI	`00844856049192`
Brand	OsseoScrew
Model	53075-55
Company	Alphatec Spine, Inc.
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K181980
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): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Thoracolumbosacral pedicle screw system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.