Arcus 16122-02-SRecalls & reported problems
Alphatec Spine, Inc. · Arcus Guided Access System - Bevel Tip, Sterile · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190376240275), received between May 13, 2021 and Apr 29, 2026 — classified as 3 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Difficult to Remove1
- Material Separation1
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
- 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.
InjuryApr 29, 2026Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE TARGETING NEEDLE BROKE DURING A CASE AND WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25032660 ↗InjuryAug 24, 2021Break; Fracture; Break; Fracture
A TARGETING NEEDLE BROKE IN THE PATIENT WHILE BEING USED BY THE SURGEON. ALL PIECES WERE RECOVERED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360431 ↗MalfunctionAug 10, 2021Fracture; Fracture
THE TARGETING NEEDLE GOT STUCK IN SCLEROTIC BONE AND BROKE WHICH CAUSED A DELAY IN SURGERY. ALL PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 12304883 ↗InjuryMay 13, 2021Difficult to Remove
DR. (B)(6) MALLETED JAMSHIDI INTO BONE, ONCE HE PUT HIS K-WIRE IN AND WENT TO TAKE JAMSHIDI OUT HE WAS NOT ABLE TO GET IT OUT OF THE BONE. HE ATTEMPTED TO TAKE A MALLET TO TRY AND GET JAMSHIDI OUT AND BY DOING THIS THE ENTIRE JAMISHIDI FELL APART WITH THE INNER STYLET STILL STUCK IN BONE. WE USED MULTIPLE INSTRUMENTS TO TRY AND GET IT OUT AND FINALLY AFTER 30 MINUTES OF TRYING IT CAME OUT.
Patient problems: Insufficient Information
MAUDE report 11821917 ↗
Other Neurosurgical nerve locator devices
- Arcus 16122-01-SAlphatec Spine, Inc. · Neurosurgical nerve locator4 reports
- SENTIO 286202400Medos International Sàrl · Neurosurgical nerve locator2 reports
- SENTIO 286202108Medos International Sàrl · Neurosurgical nerve locator2 reports
- Neurosign V4 Intraoperative Nerve Monitor 4230-00The Magstim Company Limited · Neurosurgical Nerve Locator1 report
- NVM5 NVM5MULTIEVALNuvasive, Inc. · Neurosurgical nerve locator1 report
- NVM5 2023000Nuvasive, Inc. · Neurosurgical nerve locator1 report
- SentioMMG 2006Innovative Surgical Solutions LLC · Neurosurgical Nerve Locator1 report
- ALARA Neuro Access Needle Kit AAN-09-2NSSurgentec, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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