Vital™ 801M4545Recalls & reported problems

All models of Vital (30)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868254611), received between Aug 7, 2024 and Aug 7, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Fracture3
Material Twisted/Bent3

Patient problems

Insufficient Information6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT SIX OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933897 ↗
InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME.THIS IS REPORT FIVE OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933894 ↗
InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT FOUR OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933891 ↗
InjuryAug 7, 2024Fracture; Fracture
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT THREE OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933876 ↗
InjuryAug 7, 2024Fracture; Fracture
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT TWO OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933869 ↗
InjuryAug 7, 2024Fracture; Fracture
IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT ONE OF SIX FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 19933864 ↗

Device details

UDI-DI	`00887868254611`
Brand	Vital™
Model	801M4545
Company	Biomet Spine LLC
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Bone-screw internal spinal fixation system, non-sterile

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Other Thoracolumbosacral pedicle screw system devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral pedicle screw system 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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