NA 698336915Recalls & reported problems
Depuy Spine, LLC · MODIFIED INSTRUMENT CURVED PROBE · Class 1
Data updated Oct 13, 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 10705034375540), received between Feb 9, 2021 and Feb 9, 2021 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION SURGERY A LARGE PATIENT WITH HARD BONE REQUIRED A GREAT DEAL OF TORQUE ON INSTRUMENTATION. TIPS OF THREE INSTRUMENTS BROKE DURING A CASE WITH A PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN ONE (1) MINUTE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. PATIENT STATUS IS UNKNOWN. REPLACEMENT INSTRUMENTS IMMEDIATELY AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT PRODUCT REPORTED: MOD 5.5 TAP, MOD CURVED PROBE, EXPEDIUM SI POLY-DRIVER ASSY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MOD CURVED PROBE. THIS REPORT IS 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11301201 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar Instruments 94-5923Sklar Corporation · PROBE1 recall0 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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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