Xenon 22SPT09Recalls & reported problems
Alphatec Spine, Inc. · PEDICLE PROBE, LENKE STRAIGHT · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840967190105), received between Aug 4, 2016 and Jan 9, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break7
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2023Break; Break
THE DISTAL TIP OF A PEDICLE PROBE IS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16128029 ↗MalfunctionJan 9, 2023Break; Break
THE DISTAL TIP OF A PEDICLE PROBE IS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16125235 ↗MalfunctionJan 8, 2020Break
SURGEON WAS USING IT IN THE PEDICLE AND IT BROKE RIGHT ABOVE THE SHARP POINT OF IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9563976 ↗MalfunctionNov 29, 2018Break
SURGEON WAS PUSHING THE GEAR SHIFT INTO THE PEDICLE AND THE TIP OF THE INSTRUMENT BROKE OFF. THE SURGEON EASILY REMOVED THE BROKEN TIP AND THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8116693 ↗MalfunctionMay 15, 2017Break
THE DISTAL TIP OF TWO PEDICLE PROBES WERE FOUND BROKEN UPON RETURN TO SPD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6567316 ↗MalfunctionJan 6, 2017Break
WHILE THE SURGEON WAS INSERTING THE PROBE INTO THE PEDICLE, THE INSTRUMENT SNAPPED AND GOT STUCK IN THE PEDICLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6228675 ↗MalfunctionAug 4, 2016Break
TIP OF INSTRUMENT BROKE DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5847724 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.