Momentum UU052-30-0100Recalls & reported problems
Ulrich Medical Usa, Inc. · Screwdriver for polyaxial screws, SR20, 1/4"-square · Class 2
All models of Momentum (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the Ulrich Medical screwdriver used with the Momentum thoracolumbosacral pedicle screw system to tighten screws into the spine. Most of the 48 reports describe the screwdriver tip breaking off, sometimes while the surgeon was applying extra force to seat a screw, and in at least one case a fragment was left in the patient. There are no deaths and one injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00814386025010), received between Oct 1, 2020 and Jul 25, 2024 — classified as 1 injury, 47 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (48 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
Most reported problems
Device problems
- Material Fragmentation48
- Break2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19827872 ↗MalfunctionJul 2, 2024Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP. THE DOCTOR WAS PUTTING IN A 10.0MM SCREW IN THE PATIENT AND WAS HAVING TO APPLY EXTRA FORCE TO DRIVE THE SCREW IN. UPON APPLYING THE NEEDED FORCE THE DRIVER TIP BROKE. THE TIP OF THE DRIVER WAS RETRIEVED. A SECOND DRIVER FROM THE SET WAS USED TO FINAL TIGHTEN THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19661756 ↗MalfunctionJun 13, 2024Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19530217 ↗MalfunctionApr 2, 2024Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19027527 ↗MalfunctionDec 13, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF WHILE PLACING A S1 SCREW. THE TIP WAS RETRIEVED AND DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323039 ↗MalfunctionNov 16, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156055 ↗MalfunctionNov 2, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18061690 ↗MalfunctionOct 6, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890044 ↗MalfunctionAug 23, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17607293 ↗MalfunctionAug 7, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17475684 ↗MalfunctionJul 25, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER BROKE AT THE TIP. PATIENT HAD HARD CORTICAL BONE. THE BROKEN TIP WAS REMOVED RESULTING IN A SLIGHT DELAY IN SURGERY WITH NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393359 ↗MalfunctionJun 2, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17051921 ↗MalfunctionMar 3, 2023Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482555 ↗MalfunctionNov 22, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15848073 ↗MalfunctionAug 16, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15233176 ↗MalfunctionAug 4, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIP BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15164895 ↗MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIPS BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15041598 ↗MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIPS BROKE OFF DURING SURGERRY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15041586 ↗MalfunctionJul 12, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIPS BROKE OFF DURING SURGERRY. THERE WAS NO EFFECT ON THE PATIENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14992721 ↗MalfunctionJul 12, 2022Material Fragmentation; Material Fragmentation
SCREWDRIVER TIPS BROKE OFF DURING SURGERRY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14992674 ↗InjuryMay 18, 2022Material Fragmentation; Material Fragmentation
A SCREWDRIVER TIP BROKE OFF DURING SURGERRY. THE SCREW HAD TO BE REMOVED AND REPLACED TO RETRIEVE THE SCREWDRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432293 ↗MalfunctionMay 9, 2022Material Fragmentation; No Apparent Adverse Event; Material Fragmentation; No Apparent Adverse Event
A SCREWDRIVER TIP BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14337031 ↗MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation
A SCREWDRIVER TIPS BROKE OFF DURING SURGERY. THE SCREW HAD TO BE REMOVED AND REPLACED TO RETRIEVE THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13698176 ↗MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation
A SCREWDRIVER TIPS BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13697647 ↗MalfunctionFeb 22, 2022Material Fragmentation; Material Fragmentation
A SCREWDRIVER TIPS BROKE OFF DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13578796 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
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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