MANTIS 48285545Recalls & reported problems
Stryker Corporation · CANNULATED SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540514516), received between Jun 19, 2017 and Jun 19, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Operates Differently Than Expected1
- Mechanical Problem1
Patient problems
- Injury2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2017Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; SCREW LOST THE POLYAXIALITY. IN THE INTRAOPERATIVE MOMENT, THE RIGIDITY OF THE SCREW WAS IDENTIFIED.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6652076 ↗InjuryJun 19, 2017Break; Mechanical Problem; Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT; SCREW LOST THE POLYAXIALITY. IN THE INTRAOPERATIVE MOMENT, THE RIGIDITY OF THE SCREW WAS IDENTIFIED.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6652074 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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