SPOTLIGHT 292904201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034225678), received between Sep 1, 2017 and Dec 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE KEY IS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 23906878 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO PITUITARIES WERE BROKEN AND ONE FINAL TIGHTENER WAS STRIPPED DURING A CASE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THE FRAGMENTS WERE NOT GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102972 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING A TLIF PROCEDURE ON AN UNKNOWN DATE AND DURING THE DISSECTION WAS TRYING TO BITE OFF A BONE SPUR. THE PITUITARY SNAPPED IN HALF. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693681 ↗
• InjuryFeb 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS PERFORMING A MICRODISCECTOMY THROUGH A SPOTLIGHT PORT. WHILE USING THE MICROPITUITARY, THE JAW BROKE. THE PIECE WAS DEEP IN THE PATIENT AND HAD TO BE RETRIEVED USING VARIOUS TOOLS AND THE USE OF X-RAY GUIDANCE. FRAGMENTS WERE GENERATED AND REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPOT 2MM STRAIGHT MICROPITUITA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11359123 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SPOT STRAIGHT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251528 ↗
• MalfunctionSep 1, 2017Break; Break

  INSTRUMENT BROKE DURING SURGERY. TIP LEFT IN PATIENT. PER COMPLAINT FORM: SURGEON BROKE OFF TIP OF 2MM PITUITARY FROM SPOTLIGHT INSTRUMENT SET IN DISC SPACE OF PATIENT DURING MIS MICRODISCECTOMY SURGERY. TINY PIECE WAS UNABLE TO BE REMOVED AND THUS LEFT IN PATIENT. X-RAY CONFIRMED PIECE LEFT IN L4-L5 DISC SPACE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6839816 ↗