Arsenal 47000-065-045Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL SCREW, 6.5mm X 45mm · Class 2 · Implant
All models of Arsenal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856070745), received between Sep 12, 2016 and Sep 30, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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, 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
- Break2
- Detachment of Device or Device Component1
- Difficult to Remove1
- Entrapment of Device1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2019Break; Entrapment of Device; Detachment of Device or Device Component
REVISION SURGERY WAS CONDUCTED TO REMOVE TWO POLYAXIAL SCREWS WHICH WERE FOUND TO HAVE BROKEN. THE SCREW SHANK FRACTURED & BROKE TOWARDS THE INTERFACE. THE DETACHED SECTIONS BOTH REMAINS IMPLANTED WITHIN THE PATIENTS VERTEBRAE.
Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant
MAUDE report 9135403 ↗InjurySep 12, 2016Break; Fracture; Difficult to Remove
DURING REVISION SURGERY FOR AN UNRELATED ISSUE (PATIENT CONDITION, CORONAL IMBALANCE) THE POLYAXIAL SCREW LOCATED IN THE RIGHT L5 WAS FOUND BROKE JUST BELOW THE TULIP. THE FRACTURE WAS NOT VISIBLE ON POST-OP X-RAY AND APPEARS TO HAVE OCCURRED POST-OPERATIVELY AND AFTER FUSION OCCURRED. THE THREADED SHAFT COULD NOT BE REMOVED AND REMAINS ENTRAPPED WITHIN THE L5.
Patient problems: No Code Available
MAUDE report 5943653 ↗
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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