SPOTLIGHT 292902140Recalls & reported problems
Depuy Spine, LLC · SPOTLIGHT ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 1mm · Class 1
- 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 10705034225449), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE DIRTY AFTER STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ISSUE WAS NOTED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE SPOTLIGHT ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 1MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18624634 ↗
Other RONGEUR devices
- SPOTLIGHT 292904201Depuy Spine, LLC · RONGEUR6 reports
- Symmetry RapidClean® 58-3200J-BDAspen Surgical Products, Inc. · Rongeur5 reports
- SPOTLIGHT 292904202Medos International Sàrl · RONGEUR5 reports
- NA 03.605.001Synthes GmbH · RONGEUR4 reports
- SPOTLIGHT 292902240Depuy Spine, LLC · RONGEUR3 reports
- Symmetry Rapidclean® 58-3200-BDAspen Surgical Products, Inc. · Rongeur3 reports
- Medicon 57.28.33Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR3 reports
- AESCULAP FF805RAesculap AG · RONGEUR3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.