Arcus 16122-01-SRecalls & reported problems
Alphatec Spine, Inc. · Arcus Guided Access System - Diamond Tip, Sterile · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190376240268), received between Jul 23, 2021 and Jul 24, 2024 — classified as 4 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Crack1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE GUIDED ACCESS SYSTEM BROKE INTO TWO PIECES. NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817616 ↗MalfunctionAug 10, 2021Fracture; Fracture
AFTER INSERTION IN THE PEDICLE, THE PLASTIC HANDLE BECAME LOOSE ON THE CANNULA AND COULD NOT BE USED TO SPIN AND PULL OUT. THIS CAUSED A DELAY IN SURGERY. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 12304958 ↗MalfunctionAug 10, 2021Break; Fracture; Break; Fracture
DURING SURGERY, THE NEEDLE BROKE UPON IMPACTION INTO THE VERTEBRAL BODY AND BECAME LODGED IN THE PATIENT. THIS CAUSED SURGERY TO BE DELAYED 45 MINUTES. ALL PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 12301837 ↗MalfunctionJul 23, 2021Crack; Entrapment of Device
WHILE MALLETING THE ARCUS NEEDLE INTO THE PEDICLE, THE INNER TOCAR CRACKED THE OUTER SLEEVE OF THE JAMSHIDI. THE TOCAR BECAME LODGED WITHIN THE BONE WHICH WAS VERY DIFFICULT TO REMOVE. THE PATIENT HAD VERY HARD BONE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12222179 ↗
Other Neurosurgical nerve locator devices
- Arcus 16122-02-SAlphatec Spine, Inc. · Neurosurgical nerve locator4 reports
- SENTIO 286202400Medos International Sàrl · Neurosurgical nerve locator2 reports
- SENTIO 286202108Medos International Sàrl · Neurosurgical nerve locator2 reports
- NVM5 NVM5MULTIEVALNuvasive, Inc. · Neurosurgical nerve locator1 report
- ALARA Neuro Access Needle Kit AAN-09-2NSSurgentec, LLC · Neurosurgical Nerve Locator1 report
- Neurosign V4 Intraoperative Nerve Monitor 4230-00The Magstim Company Limited · Neurosurgical Nerve Locator1 report
- SentioMMG 2006Innovative Surgical Solutions LLC · Neurosurgical Nerve Locator1 report
- BMAN Solid Diamond Needle SR07-1100Surgentec, LLC · Neurosurgical Nerve Locator1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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