TRIALTISRecalls & reported problems across all models
Medos International Sàrl · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 182
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 46 models of TRIALTIS by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 182 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2024 and Sep 25, 2026 — classified as 48 injuries, 134 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (55 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TRIALTIS problems
Device problems
- Material Twisted/Bent55
- Material Deformation47
- Adverse Event Without Identified Device or Use Problem38
- Break27
- Failure to Cut17
- Device-Device Incompatibility15
- Migration7
- Device Slipped6
Patient problems
- No Clinical Signs, Symptoms or Conditions125
- Unspecified Infection38
- Insufficient Information19
- Foreign Body In Patient2
TRIALTIS models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRIALTIS 5161-00-5046DRIVER, PROSTHESIS26 reports
- TRIALTIS 5560-01-0000Thoracolumbosacral pedicle screw system23 reports
- TRIALTIS 5161-00-0060TAP, BONE16 reports
- TRIALTIS 5161-00-5006SCREWDRIVER16 reports
- TRIALTIS 5560-12-6050FThoracolumbosacral pedicle screw system8 reports
- TRIALTIS 5161-00-5089Orthopedic stereotaxic instrument6 reports
- TRIALTIS 5161-00-5069Orthopedic stereotaxic instrument5 reports
- TRIALTIS 5161-00-5034Orthopedic manual surgical instrument5 reports
- TRIALTIS 5560-12-4530FSThoracolumbosacral pedicle screw system4 reports
- TRIALTIS 5560-12-4535FSThoracolumbosacral pedicle screw system4 reports
- TRIALTIS 5161-00-5058SCREWDRIVER4 reports
- TRIALTIS 5161-00-4070TAP, BONE4 reports
- TRIALTIS 5560-55-3065TThoracolumbosacral pedicle screw system4 reports
- TRIALTIS 5161-00-1070Orthopedic stereotaxic instrument3 reports
- TRIALTIS 5161-00-1080Orthopedic stereotaxic instrument3 reports
- TRIALTIS 5161-00-5116Orthopedic stereotaxic instrument3 reports
- TRIALTIS 5161-00-0050TAP, BONE3 reports
- TRIALTIS 5161-00-5035Orthopedic manual surgical instrument3 reports
- TRIALTIS 5560-01-00X8SThoracolumbosacral pedicle screw system3 reports
- TRIALTIS 5161-00-1075Orthopedic stereotaxic instrument2 reports
- TRIALTIS 5161-00-1085Orthopedic stereotaxic instrument2 reports
- TRIALTIS 5161-00-0040TAP, BONE2 reports
- TRIALTIS 5161-00-0080TAP, BONE2 reports
- TRIALTIS 5560-12-6045FThoracolumbosacral pedicle screw system2 reports
- TRIALTIS 5560-55-2480TThoracolumbosacral pedicle screw system2 reports
- TRIALTIS 5161-00-5065Orthopedic manual surgical instrument2 reports
- TRIALTIS 5161-00-4100TAP, BONE2 reports
- TRIALTIS 5161-00-4090TAP, BONE2 reports
- TRIALTIS 5161-00-4110TAP, BONE2 reports
- TRIALTIS 5161-00-4120TAP, BONE2 reports
- TRIALTIS 5161-00-4040TAP, BONE2 reports
- TRIALTIS 5161-00-1100Orthopedic stereotaxic instrument1 report
- TRIALTIS 5161-00-1110Orthopedic stereotaxic instrument1 report
- TRIALTIS 5161-00-1120Orthopedic stereotaxic instrument1 report
- TRIALTIS 5161-00-1065Orthopedic stereotaxic instrument1 report
- TRIALTIS 5161-00-1090Orthopedic stereotaxic instrument1 report
- TRIALTIS 5161-00-0070TAP, BONE1 report
- TRIALTIS 5560-12-6045Thoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-55-4045TThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-60-2480CThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-60-2480TThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5161-00-4080TAP, BONE1 report
- TRIALTIS 5560-12-7045CSThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-13-8080CDThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-13-8080DThoracolumbosacral pedicle screw system1 report
- TRIALTIS 5560-55-3095TThoracolumbosacral pedicle screw system1 report
Recent TRIALTIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the driver tip is stripped. There was no patient harm and no surgical delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899677 ↗MalfunctionSep 25, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899670 ↗MalfunctionSep 4, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616764 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356586 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356581 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356579 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356575 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356573 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356568 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351357 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351353 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351352 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351269 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351264 ↗MalfunctionAug 20, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351156 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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