SPOTLIGHT 292904202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034225685), received between Apr 26, 2019 and Jan 8, 2025 — classified as 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 21102990 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PITUITARY WOULD NOT CLOSE ALL THE WAY. UPON INSPECTION INTRAOPERATIVELY, IT WAS DISCOVERED THE DEVICE HAD A SHEARED PIN/SCREW. ANOTHER SET WAS OPENED FOR THE SURGEON TO USE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR AN ANGLE MICRO PITUITARY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461653 ↗
• MalfunctionAug 15, 2019Break; Break

  THE ITEM #279702040 GOT BENT AND TWISTED DURING HOLE CREATION IN HARD BONE. THE TIP OF ITEM 292904202 BROKE WHILE THE SURGEON WAS TRYING TO REMOVE TISSUE. THE BROKEN PIECE WAS RETRIEVED AND DISCARDED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898517 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED ON (B)(4) 2019 DURING MICRODISCECTOMY, THE SPOTLIGHT ACCESS SYSTEM UP ANGLE MICROPITUITARY WAS BROKEN, SURGEON REMOVED THE BROKEN PIECE WITH DIFFICULTY. PROCEDURE OUTCOME AND PATIENT CONSEQUENCE ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704927 ↗
• MalfunctionApr 26, 2019Break; Break

  THE FOLLOWING WAS REPORTED: ITEM 2929-04-201: THE SCREW HOLDING THIS INSTRUMENT TOGETHER WAS MISSING WHEN THE INSTRUMENT WAS TAKEN OUT OF THE PAN. IT WAS THEREFORE NOT USABLE. ITEM 2929-04-202: THE TIP OF THIS INSTRUMENT BENT AND EVENTUALLY BROKE OFF AS THE SURGEON WAS USING THIS INSTRUMENT TO REMOVE SMALL BONE FRAGMENTS. NO PIECE FELL INTO THE PATIENT BUT THE MISSING PIECE WAS DISCARDED. ITEM 2867-25-020: THE TIP OF THIS SCREW DRIVER WAS STRIPPED AND TWISTED AS THE SURGEON WAS TRYING TO REMOVE A SCREW WHICH WAS VERY HARD TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558449 ↗