Arsenal 47000-065-050Recalls & reported problems
Alphatec Spine, Inc. · POLYAXIAL SCREW, 6.5mm X 50mm · 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 00844856070752), received between Mar 24, 2020 and Mar 24, 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
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2020Break
DURING REVISION SURGERY FOR AN UNRELATED EVENT, THE TULIPS OF TWO POLYAXIAL SCREW WERE DISCOVERED BROKEN. ADDITIONALLY, WHILE PERFORMING THE XLIF OF THE L2-L3, IT WAS ALSO NOTICED NEITHER SET SCREWS IN L3 WERE THREADED. SURGEON DECIDED TO FINISH PATIENT AND THEN FLIP AND REVISE THE EXISTING HARDWARE. GOT EVERYTHING 100 PERCENT EXPLANTED FOR REVISION DOWN TO L5. BECAUSE A FULL REVISION HAD BECOME NECESSARY, THE CASE WAS EXTENDED GREATER THAN 30 MINUTES. THE ARSENAL SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9873957 ↗
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- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
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- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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