Boston Endo Surgical Technologies LLC PK1015Recalls & reported problems
Lacey Manufacturing Company, LLC · Pedicle Access Needle- NIM Pedicle Probe Straight · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853508002362), received between Sep 30, 2022 and Sep 30, 2022 — classified as 1 malfunction.
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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2022Break
APPROXIMATELY 1 CM TIP BROKE OFF OF PEDICLE PROBE AND WAS RETAINED IN PATIENT'S BACK. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15527706 ↗
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- 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
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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