Momentum UU051-01-5545Recalls & reported problems

Ulrich Medical Usa, Inc. · Screw, polyaxial, Ø 5.5mm, length 45mm, cannulated, fenestrated · Class 2 · Implant

All models of Momentum (19)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814386023177), received between Apr 17, 2025 and Apr 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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

Break2

Patient problems

Back pain2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryApr 17, 2025Break; Break
THE PATIENT COMPLAINED OF PAIN; AFTER DOING A CAT SCAN THE SURGEON BECAME CONCERNED REGARDING THE "WEIRD PRESENTATION" OF THE SCREWS AND OPTED TO PERFORM A MINI-REVISION ON 3/20. DURING THE CASE ON 3/20 X3 TOTAL SCREWS WERE BROKEN, 2 5.5X45MM PEDICLE SCREWS (BROKEN AT THE TIP) AND A 9.0X90MM ILIAC SCREW (BROKEN NEAR THE TOP OF THE SCREW BUT BELOW THE TULIP HEAD). CEMENT WAS NOT USED WHEN THESE SCREWS WERE IMPLANTED AND THE TIPS OF BOTH PEDICLE SCREWS WERE LEFT IN THE PATIENT AS WAS THE ILIAC SCREW. THE PEDICLE SCREWS HAD BEEN IN THE PATIENT SINCE 2022 AND THE ILIAC SCREW HAD BEEN IN SINCE 2021. THERE IS NO EVIDENCE TO SUGGEST THAT THESE SCREWS WERE BROKEN PRIOR TO THEIR ATTEMPTED REMOVAL ON (B)(6) AND THE SURGEON ONLY PERFORMED THIS REVISION DUE TO THE PATIENT COMPLAINING OF PAIN AND THE PRESENTATION OF THE SCREWS ON THE CAT SCAN.
Patient problems: Back pain
MAUDE report 21861971 ↗
InjuryApr 17, 2025Break; Break
THE PATIENT COMPLAINED OF PAIN, AFTER DOING A CAT SCAN THE SURGEON BECAME CONCERNED REGARDING THE "WEIRD PRESENTATION" OF THE SCREWS AND OPTED TO PERFORM A MINI-REVISION ON (B)(6). DURING THE CASE ON (B)(6) X3 TOTAL SCREWS WERE BROKEN, 2 5.5X45MM PEDICLE SCREWS(BROKEN AT THE TIP) AND A 9.0X90MM ILIAC SCREW(BROKEN NEAR THE TOP OF THE SCREW BUT BELOW THE TULIP HEAD). CEMENT WAS NOT USED WHEN THESE SCREWS WERE IMPLANTED AND THE TIPS OF BOTH PEDICLE SCREWS WERE LEFT IN THE PATIENT AS WAS THE ILIAC SCREW. THE PEDICLE SCREWS HAD BEEN IN THE PATIENT SINCE 2022 AND THE ILIAC SCREW HAD BEEN IN SINCE 2021. THERE IS NO EVIDENCE TO SUGGEST THAT THESE SCREWS WERE BROKEN PRIOR TO THEIR ATTEMPTED REMOVAL ON (B)(6) AND THE SURGEON ONLY PERFORMED THIS REVISION DUE TO THE PATIENT COMPLAINING OF PAIN AND THE PRESENTATION OF THE SCREWS ON THE CAT SCAN.
Patient problems: Back pain
MAUDE report 21860630 ↗

Device details

UDI-DI	`00814386023177`
Brand	Momentum
Model	UU051-01-5545
Company	Ulrich Medical Usa, Inc.
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K191932
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	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.

Other Thoracolumbosacral Pedicle Screw System devices

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Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
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EXPEDIUM VERSE 199721001S
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LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
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LineSider LS-N6SA6545
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EXPEDIUM VERSE 199721000S
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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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