ArsenalRecalls & reported problems across all models
Alphatec Spine, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 86
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 18 models of Arsenal by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2016 and Apr 27, 2026 — classified as 20 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Break” (73 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Arsenal problems
Device problems
- Break73
- Material Separation19
- Detachment of Device or Device Component7
- Fracture7
- Device Dislodged or Dislocated4
- Entrapment of Device3
- Detachment Of Device Component2
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient14
- No Code Available8
- No Consequences Or Impact To Patient7
- Device Embedded In Tissue or Plaque3
- Insufficient Information3
- Failure of Implant2
- Foreign Body In Patient2
Arsenal models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arsenal 87134SCREWDRIVER36 reports
- Arsenal 87011SCREWDRIVER17 reports
- Arsenal 87771Orthopedic stereotaxic instrument6 reports
- Arsenal 87107-055TAP, BONE5 reports
- Arsenal 87013SCREWDRIVER5 reports
- Arsenal 47027Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- Arsenal 47000-065-045ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- Arsenal 48007-55-500Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- Arsenal 48500-095-090APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Arsenal 87012SCREWDRIVER1 report
- Arsenal 47000-065-050Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- Arsenal 47000-075-055Orthosis, spondylolisthesis spinal fixation1 report
- Arsenal 47000-095-080Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Arsenal 48001-55-500ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Arsenal 47006-47ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Arsenal 47100-065-055Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- Arsenal 47400-055-030Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- Arsenal 47400-055-035Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
Recent Arsenal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THE DRIVER TIP WAS FOUND TO BE TWISTED WITH A PORTION OF THE DISTAL TIP MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25005435 ↗MalfunctionMar 5, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS NOT WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523679 ↗MalfunctionDec 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924581 ↗MalfunctionDec 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS TWISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817346 ↗MalfunctionDec 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23807230 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682535 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682293 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681889 ↗MalfunctionNov 4, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER WAS NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466714 ↗MalfunctionOct 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292722 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS NOT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843783 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22788007 ↗MalfunctionJun 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRIVER BROKE WHILE TAKING OUT A SCREW FOR AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287600 ↗MalfunctionJun 11, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN A SET SCREW WHILE FINAL TIGHTENING DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187246 ↗MalfunctionApr 29, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER ARRIVED WITH THE TIP BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931270 ↗
Other Alphatec Spine, Inc. products
- Invictus96 models · 448 reports
- IdentiTi31 models · 68 reports · 1 recall
- ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
- Calibrate44 models · 40 reports · 1 recall
- Illico20 models · 69 reports
- AMP5 models · 4 reports · 1 recall
- Insignia34 models · 54 reports
- Trestle Luxe24 models · 38 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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