NA 388.545Recalls & reported problems
Synthes GmbH · STRAIGHT BALL TIP 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 10705034773490), received between Jan 31, 2019 and Jan 31, 2019 — 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 Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A PEDIATRIC SCOLIOSIS PROCEDURE, TWO (2) SPINAL INSTRUMENTS WERE REPORTED AS BROKEN DURING SURGERY. AN EXPEDIUM VERSE CURVED PEDICLE THORACIC PROBE WAS BENT WHILE BEING PUSHED AGAINST THE BONE AND NOW UNUSABLE AND A FEELER FOR SCREW CHANNEL STRAIGHT WAS BROKEN INTO TWO PIECES. FRAGMENTS WERE GENERATED FROM THE FEELER BUT WERE EASILY REMOVED. ANOTHER STOCK OF THE SAME DEVICES WAS USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) STRAIGHT BALL TIP PROBE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8294237 ↗
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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