VIPER 286715500NRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034388489), received between Jun 1, 2020 and May 22, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 5.0 CANNULATED TAP TIP BROKE OFF DURING SURGERY IN THE PATIENT¿S VERTEBRAL BODY. ITEM WAS REMOVED WITH AN EASY-OUT DEVICE FROM A SCREW REMOVAL SET BUT SPLIT IN HALF IN DOING SO. THERE WAS 60 MINS OF SURGICAL DELAY. TAP PIECE WAS REMOVED BY USING EASY OUT SCREW REMOVAL DEVICES. TAP SPLIT IN HALF VERTICALLY AS WELL DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SURGEON WAS STILL ABLE TO PLACE SCREWS IN THAT VB BUT ELECTED TO FUSE AN ADDITIONAL LEVEL AS WELL TO ASSURE FIXATION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071845 ↗
• MalfunctionSep 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024 THE TAP BROKE WHILE USING IT. THE TIP REMAINS IN THE PATIENT. IT IS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY OR WITH SURGICAL DELAY. FRAGMENTS WERE GENERATED AND REMAINED IN THE PATIENT. THIS REPORT IS FOR 5MM TAP, DUAL LEAD CANN FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20201225 ↗
• InjuryApr 29, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT BY THE SALES REP THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2022, WHILE TAPPING FOR A PEDICAL SCREW, IT WAS OBSERVED THAT THE 6MM TAP SNAPPED BY 1 CM FROM THE TIP WHILE REMOVING IT FROM THE BONE. ACCORDING TO THE REPORT, WHILE TAPPING ANOTHER PEDICAL WITH A 5MM TAP, IT WAS OBSERVED THAT THE TAP SNAPPED 1 CM FROM THE TIP WHILE REMOVING IT. ALL THE FRAGMENTS WERE REMOVED. THERE WAS A SURGICAL DELAY OF TWO HOURS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 5MM TAP, DUAL LEAD CANN DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253246 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SPINAL FUSION SURGERY. DURING THE SURGERY, THE INSTRUMENT BROKE AT THE THREAD PITCH. THE BROKEN PORTION WAS REMOVED EASILY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20 MINUTES DELAY. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN POWER DRILL SET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 5MM TAP, DUAL LEAD CANN. THIS REPORT IS 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968125 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A LUMBAR FUSION L4/5 SURGERY, THE TWO CANNULATED VIPER TAPS BROKE OFF INTO THE PEDICLES RIGHT ABOVE THE THREADS. ONE IN EACH PEDICLE. A SYNTHES SCREW REMOVAL SET WAS USED TO EXTRACT THE PIECES. FRAGMENTS WERE GENERATED AND REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10106396 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(4) 2020, DURING A LUMBAR FUSION L4/5 SURGERY, THE TWO CANNULATED VIPER TAPS BROKE OFF INTO THE PEDICLES RIGHT ABOVE THE THREADS. ONE IN EACH PEDICLE. A SYNTHES SCREW REMOVAL SET WAS USED TO EXTRACT THE PIECES. FRAGMENTS WERE GENERATED AND REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10106394 ↗