Streamline MIS Spinal Fixation System 05-PA-65-50Recalls & reported problems
Xtant Medical Holdings, Inc. · CANNULATED SCREW, POLYAXIAL · Class 2 · Implant
Data updated Oct 18, 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 00191083019604), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Detachment of Device or Device Component
THE MANUFACTURER WAS CONTACTED ON 01/08/2026 TO REPORT AN ISSUE WITH A MIS SCREW. IT WAS REPORTED THAT DURING A POSTERIOR FUSION AT L3-L5, DURING FINAL TIGHTENING OF THE LAST SCREW IN A CONSTRUCT, THE TULIP OF THE SCREW DISSOCIATED FROM THE SHANK. SINCE THE OTHER SCREWS IN THE CONSTRUCT WERE FINAL TIGHTENED AND THE SCREW WITH THE DISSOCIATED TULIP WAS NOT AT EITHER END OF THE CONSTRUCT, THE DISSOCIATED TULIP AND SCREW SHANK WERE LEFT IN PLACE.LATERAL X-RAY IMAGES PROVIDED BY THE COMPLAINANT SHOWED 6 IMPLANTED SCREWS CONNECTED BY TWO RODS, ONE OF THE SCREWS HAD ITS TULIP DISSOCIATED FROM THE SHANK OF THE SCREW. THE DISSOCIATED TULIP OF THE SCREW REMAINED SEATED IN PLACE ON THE IMPLANTED ROD. THE SCREW WITH THE DISSOCIATED TULIP WAS THE MIDDLE SCREW IN A SERIES OF THREE. THE SHANK OF THE SCREW WITH THE DISSOCIATED TULIP APPEARED TO BE SEATED FURTHER INTO THE PATIENT'S BONE THAN THE OTHER SCREWS USED FOR FIXATION. ADDITIONALLY, UNKNOWN INTERVERTEBRAL IMPLANTS APPEAR IN BETWEEN THE LEVELS OF FIXATION .
Patient problems: Failure of Implant
MAUDE report 24283672 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page