OsseoScrew 53165-45Recalls & reported problems

Alphatec Spine, Inc. · OSSEOSCREW F TI HIGH TOP 6.5 X 45MM · 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 00844856049055), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 injury.

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

Fracture1

Patient problems

Unspecified Infection1

Recent adverse event reports

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

InjuryDec 30, 2021Fracture; Fracture
A (B)(6) MALE UNDERWENT A POSTERIOR FIXATION SURGERY AT T10-PELVIS. ONE YEAR POSTOP, RADIOGRAPHS REVEALED AN OSSEOSCREW AT T10-T11 HAD PULLED OUT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DURING SURGERY, THE SURGEON NOTED THE PATIENT HAD DEVELOPED AN INFECTION WHICH CAUSED THE CONSTRUCT TO BECOME LOOSE RESULTING IN THE OSSEOSCREW TO PULL OUT. ALL IMPLANTS WERE REMOVED DUE TO THE INFECTION. THE LEFT T10 OSSEOSCREW WAS FOUND TO BE BENT AND FRACTURED AT THE EXPANSION REGION. THE LEFT T10 DISTAL TIP, RIGHT T11 DISTAL TIP, AND T12 LEFT DISTAL TIP WERE UNABLE TO BE RETRIEVED. THE PATIENT WILL NEED TO UNDERGO ANOTHER SURGERY IN ORDER TO STABILIZE HIS SPINE.
Patient problems: Unspecified Infection
MAUDE report 13122227 ↗

Device details

UDI-DI	`00844856049055`
Brand	OsseoScrew
Model	53165-45
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.