NA 03.614.012Recalls & reported problems
Synthes GmbH · PEDICLE PROBE 2.4MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034714844), received between Apr 13, 2018 and Apr 13, 2018 — classified as 1 injury.
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.
InjuryApr 13, 2018Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2018, WHEN THE SURGEON WAS USING THE PEDICLE PROBE, THE TIP OF THE PEDICLE PROBE BROKE INSIDE THE PEDICLE OF THE PATIENT'S VERTEBRAE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE FROM THE PEDICLE OF THE VERTEBRAE AS HE DID NOT WANT TO COMPROMISE THE INTEGRITY OF THE PATIENT'S PEDICLE. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) PEDICLE PROBE 2.4MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 7430345 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- Sklar Instruments 94-5923Sklar 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 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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