Arsenal 47000-075-055Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL SCREW, 7.5mm X 55mm · Class 2 · Implant
All models of Arsenal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856070998), received between Mar 3, 2020 and Mar 3, 2020 — classified as 1 injury.
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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2020Break; Loosening of Implant Not Related to Bone-Ingrowth
A PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2020. THE CASE WAS CONDUCTED BECAUSE THE PATIENT HAD PSEUDOARTHROSIS AND SCREWS HAD LOOSENED. WHILE REMOVING THE LOOSENED SCREW AT THE SACRUM TO REPLACE IT WITH NEW ONE, IT WAS FOUND BROKEN. THE PROXIMAL SECTION WAS REMOVED WHILE DISTAL PORTION, APPROXIMATELY 40MM REMAINS IMPACTED WITHIN THE PATIENT'S SACRUM. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE. THE ARSENAL SPINAL FIXATION SYSTEM WAS INITIALLY IMPLANTED ON (B)(6) 2019 AS A REPLACEMENT AND EXTENSION FOR A PREVIOUSLY IMPLANTED ZODIAC CONSTRUCT.
Patient problems: No Code Available
MAUDE report 9780203 ↗
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- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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