SPOTLIGHT 292900600Recalls & reported problems
Depuy Spine, LLC · SPOTLIGHT ACCESS SYSTEM RIGID ARM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034225340), received between May 21, 2019 and Jan 29, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Contamination /Decontamination Problem3
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- Tissue Damage1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Break; Contamination /Decontamination Problem
IT WAS REPORTED ON (B)(6) 2026, IT WAS NOTED THE PLASTIC PIECE ON THE RIGID ARM BROKE DURING STERILIZATION, LEAVING A BLACK RESIDUE IN THE PAN AND ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210233 ↗MalfunctionJan 29, 2026Break; Contamination /Decontamination Problem
IT WAS REPORTED ON JANUARY 15, 2026, IT WAS NOTED THE PLASTIC PIECE ON THE RIGID ARM BROKE DURING STERILIZATION, LEAVING A BLACK RESIDUE IN THE PAN AND ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210228 ↗MalfunctionJan 29, 2026Break; Contamination /Decontamination Problem
IT WAS REPORTED ON JANUARY 15, 2026, IT WAS NOTED THE PLASTIC PIECE ON THE RIGID ARM BROKE DURING STERILIZATION, LEAVING A BLACK RESIDUE IN THE PAN AND ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210214 ↗MalfunctionAug 5, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON JULY 11, 2024, THE KNOB OF THE RIGID ARM WAS DAMAGED WHEN IT CAME ACROSS A THREAD. IT NEEDED TO BREAK THE KNOB OFF SINCE IT WAS HOLDING THE PORT, WHICH THE DOCTOR NEEDED TO REMOVE FROM THE PATIENT URGENTLY. HOWEVER, BECAUSE IT WAS CROSS-THREADED, IT COULD NOT BE TURNED AND NEEDED TO BE FORCEFULLY REMOVED. THE THREADS AND KNOB ARE NOW DAMAGED, RENDERING THE RIGID ARM USELESS. THIS REPORT INVOLVES ONE SPOTLIGHT ACCESS SYSTEM RIGID ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19908020 ↗InjuryMay 21, 2019Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON (B)(6) 2019, DURING A MINIMALLY INVASIVE MICRODISCECTOMY (MIS), THE SPOTLIGHT RIGID ARM WAS NOT ARTICULATING. THE SURGEON STATED THAT THERE WAS A REPEAT FAILURE OF THE BED ATTACHMENT AND HOPELESSLY INAPPROPRIATE REVERSAL TO OPEN SURGERY FOR WHICH THE PATIENT WASN'T EXPECTING. THIS HAPPENED THE SECOND TIME WITHIN A COUPLE OF WEEKS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN.
Patient problems: Tissue Damage
MAUDE report 8628064 ↗
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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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