KARMA 75311-095Recalls & reported problems
Spinal Elements, Inc. · DRILL CARTRIDGE - .095 SHAFT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840606158237), received between Oct 4, 2023 and May 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Mechanical Problem2
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Unraveled Material
DURING FACET BONE PREPARATION FOR A FACET STABILIZATION FOR SPINAL FUSION, THE CANTED COIL OF THE DRILL UNWOUND AND MADE THE DRILL UNFUNCTIONAL. BACKUP DRILL WAS NOT AVAILABLE AND DIRECT DECOMPRESSION OF THE NERVE ROOT WAS PERFORMED AND THE FIXATION AT THAT LEVEL WAS ABANDONED. THOUGH THE SURGERY WAS COMPLETED, THE DEVICE COULD NOT BE USED AS A RESULT OF THE MALFUNCTION. THERE WAS A PARTIAL DECORTICATION OF THE BONE AS A RESULT OF ATTEMPTING THIS PROCEDURE. PATIENT IS ASYMPTOMATIC.
Patient problems: Perforation
MAUDE report 25143334 ↗MalfunctionDec 15, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem
REPORTEDLY DURING DECORTICATION OF LAMINA AT L4-S1, 2 OUT 5 ORTHOPEDIC DRILL TIP FRACTURED OFF INSIDE THE LAMINA. SURGEON WAS UNSUCCESSFUL AT RETRIEVING TWO TIPS. HE ELECTED TO LEAVE THE DEVICE TIPS IN PLACE. HE SELECTED A DIFFERENT TRAJECTORY AROUND IT TO COMPLETE THE SPINAL FUSION CASE. BILATERAL POSTERIOR FIXATION WAS ACHIEVED. REPORTEDLY THE YOUNG PATIENT HAD VERY DENSE POSTERIOR BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18340770 ↗MalfunctionOct 4, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem
REPORTEDLY DURING DECORTICATION OF LAMINA AT L4-L5, THE ORTHOPEDIC DRILL TIP FRACTURED OFF INSIDE THE LAMINA. SURGEON WAS UNSUCCESSFUL AT RETRIEVING THE TIP. HE ELECTED TO LEAVE THE DEVICE TIP IN PLACE. HE SELECTED A DIFFERENT TRAJECTORY AROUND IT TO COMPLETE THE SPINAL FUSION CASE. BILATERAL POSTERIOR FIXATION WAS ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17871175 ↗
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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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