Streamline MIS Spinal Fixation System 05-PA-65-40Recalls & 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 00191083019581), received between Jun 17, 2022 and Jun 17, 2022 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unintended Movement1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2022Break; Detachment of Device or Device Component; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Break; Detachment of Device or Device Component; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth
"POST OP X-RAY REVEALED THAT A MIS TULIP HEAD CAME OFF A SCREW AT L5 ON WEDNESDAY 5/11. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY 5/16 AT BARNES WEST COUNTY. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW, ROD, AND SET SCREW."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14733532 ↗
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.
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