MANTIS 48285440Recalls & reported problems
Stryker Corporation · CANNULATED SCREW · Class 2 · Implant
All models of MANTIS (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540567239), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Partial Blockage” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Partial Blockage1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2018Partial Blockage
IT IS REPORTED THAT DURING A HELICAL REMOVAL OF THE SCREW, THE SCREW HEAD GOT BLOCKED LATERALLY, CAUSING POTENTIAL CONSEQUENCES ON THE MUSCLE TISSUE. THE SCREW WAS REMOVED WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT, AND NO DELAY. PER EMAIL CORRESPONDENCE, THE REMOVAL SURGERY WAS DUE TO MEDICAL DECISION DUE TO PAIN. THERE IS NO INDICATION OF PRODUCT RELATED ISSUE WHICH RESULTED IN THE REPORTED PAIN OR THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 7285967 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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