Arsenal 47027Recalls & reported problems
Alphatec Spine, Inc. · SET SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844856070325), received between Feb 24, 2016 and Apr 25, 2017 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Detachment Of Device Component1
Patient problems
- No Code Available2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2017Device Dislodged or Dislocated
AT 4.5 MONTH POST-OP X-RAYS REVEALED THE ARSENAL SET SCREW LOCATED AT THE S1 HAD DISENGAGED/BACKED OUT FROM THE HEAD OF THE POLYAXIAL SCREW BODY. HOWEVER, THE ROD REMAINED PROPERLY POSITIONED AND ALLOWED FUSION/HEALING TO OCCUR. THE CONSTRUCT HAS BEEN IMPLANTED FOR APPROXIMATELY 2.5 YEARS WITHOUT ISSUE. THERE ARE NO PLANS FOR REVISION AT THIS TIME. THE ARSENAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2014.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6518796 ↗InjuryOct 11, 2016Detachment Of Device Component
TWO ARSENAL SET SCREWS (47027) WERE FOUND DETACHED FROM THE TULIP OF THE MATING POLYAXIAL SCREWS LOCATED AT BOTH THE RIGHT AND LEFT SIDES OF THE S1. THE PATIENT WAS REPORTED TO HAVE ALREADY FUSED/HEALED. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE THE L4-S1 CONSTRUCT.
Patient problems: No Code Available
MAUDE report 6017885 ↗InjuryFeb 24, 2016Device Dislodged or Dislocated
REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE AND REPLACE 3 ARSENAL SET SCREWS AT THE L5-S1. THE SET SCREWS WERE FOUND TO HAVE BACKED OUT OF POSITION ONE MONTH POST-OP. THE ARSENAL SPINAL FIXATION WAS ORIGINALLY IMPLANTED ON (B)(6) 2015.
Patient problems: No Code Available
MAUDE report 5457228 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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