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Xenon 22SPT10Recalls & reported problems

Alphatec Spine, Inc. · PEDICLE PROBE, LENKE CURVED · 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 00840967190112), received between May 3, 2016 and Sep 13, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

  • Break6
  • Fracture1
  • Material Separation1

Patient problems

  • No Known Impact Or Consequence To Patient5
  • No Clinical Signs, Symptoms or Conditions1
  • 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.

  • MalfunctionSep 13, 2020Material Separation

    PROBE BROKE IN PEDICLE. THE DETACHED TIP WAS REMOVED WITHOUT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10526177 ↗
  • MalfunctionMar 3, 2020Break

    TIP OF PROBE BROKEN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9780321 ↗
  • MalfunctionFeb 24, 2020Break

    SURGEON WAS INSERTING THE PROBE INTO PEDICLE WITH SOME DOWNWARD FORCE AND IT SNAPPED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9745731 ↗
  • MalfunctionSep 17, 2019Break

    SURGEON WAS USING IT AND IT BROKE WHILE HE WAS TRYING TO PUT IT IN THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9075980 ↗
  • MalfunctionNov 7, 2018Break

    SURGEON WAS USING PEDICLE PROBE AND AS HE WAS TRYING TO PUSH IT DOWN IT BROKE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8046662 ↗
  • MalfunctionNov 7, 2018Break

    SURGEON WAS USING PEDICLE PROBE AND AS HE WAS TRYING TO PUSH IT DOWN IT BROKE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8046555 ↗
  • MalfunctionMay 3, 2016Break; Fracture

    THE TIP OF CURVED PROBE FRACTURED AND BROKE DURING USE. THE EVENT CAUSED NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5624718 ↗

Other PROBE devices

All PROBE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.