VIPER 286715600Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034214092), received between Aug 14, 2018 and Jun 20, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A 6MM TAP BIT BROKE INTO THE PEDICLE + VERTEBRAL BODY (L2 VERTEBRAE, LEFT PEDICLE, VERY SCLEROTIC BONE). SURGEON TRIED TO REMOVE THE BROKEN PIECE WITH A SCREW REMOVAL SET, BUT IT WAS IMPOSSIBLE TO REMOVE. THE SURGEON DECIDED TO LEFT THE TAP BIT IN PLACE. THERE WAS A 30 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22302128 ↗
• MalfunctionDec 16, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A TLIF (L4/5) FOR SPINAL STENOSIS. A 6 MM DIAMETER TAP WAS USED BECAUSE THE ENTIRE L5 VERTEBRA WAS OSTEOSCLEROTIC. THE TAP BROKE OFF AFTER APPROXIMATELY 40 MM INSERTION. IT TOOK APPROXIMATELY 30 MINUTES TO REMOVE THE BROKEN TAP TIP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY 60 MINUTES DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938918 ↗
• MalfunctionNov 22, 2024Break; Failure to Cut; Material Twisted/Bent; Break; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED THAT THE ITEM WAS BLUNT AND BROKE OFF WHEN TURNED BACK. ARTICLE WAS WORN OUT AND SHOULD NOT HAVE BEEN SENT IF CHECKED BEFOREHAND. THERE WAS NO PATIENT DAMAGE ACCORDING TO THE SURGEON. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759632 ↗
• MalfunctionMar 12, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF COULD NOT THREAD THE GUIDE WIRE DOWN BACK OF TWO VIPER TAPS AS THERE WAS SOMETHING BLOCKING GUIDE WIRE FROM FUNNELING DOWN. THE SURGEON TRIED DIFFERENT GUIDEWIRES (X2) AND HANDLES AND THOSE WERE NOT THE ISSUE. THE GUIDE WIRES SNAPPED AFTER TRYING TO GET THEM THROUGH TAP. FINALLY THE THIRD TAP WAS TRIED AND WORKED WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE VIPER2 6MM SELF DRILLING TAP. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885455 ↗
• MalfunctionMar 12, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF COULD NOT THREAD THE GUIDE WIRE DOWN BACK OF TWO VIPER TAPS AS THERE WAS SOMETHING BLOCKING GUIDE WIRE FROM FUNNELING DOWN. THE SURGEON TRIED DIFFERENT GUIDEWIRES (X2) AND HANDLES AND THOSE WERE NOT THE ISSUE. THE GUIDE WIRES SNAPPED AFTER TRYING TO GET THEM THROUGH TAP. FINALLY THE THIRD TAP WAS TRIED AND WORKED WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) VIPER2 6MM SELF DRILLING TAP. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885344 ↗
• MalfunctionJan 11, 2024Break; Break

  PATIENT STATUS/ OUTCOME: GOOD OUTCOME, LEFT HOSPITAL THIS WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490857 ↗
• MalfunctionNov 15, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A POSTERIOR LUMBAR SPINAL FUSION OCCURRED ON (B)(6) 2023. IN THE SURGERY, WHEN THE S1 VERTEBRA WAS TAPPED WITH THE DRILLING TAP IN QUESTION, THE BONE MATERIAL WAS HARD AND THE TIP WAS BROKEN. BECAUSE IT WAS EMBEDDED IN THE BONE, REMOVAL WAS ABANDONED AND IT WAS LEFT INSIDE THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT THE BONE WAS OF HARD QUALITY AND TOO MUCH TORQUE MIGHT HAVE BEEN APPLIED DURING THE TAPPING PROCESS. THIS REPORT IS FOR (B)(4). FOR VIPER 2 SYSTEM TAP.

  Patient problems: Foreign Body In Patient

  MAUDE report 18138428 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT THIS WAS A TLIF FOR TREATING SPONDYLOLISTHESIS. THE SURGEON TRIED PROBING WITH THE TAP IN QUESTION AGAINST THE EXTREMELY ROBUST BONE. AS THE SURGEON TRIED TO EFFECT SUFFICIENT PROBING AT L4 RIGHT, THE TAP ADVANCED FURTHER AND REACHED THE POSTERIOR WALL OF THE CENTRUM. THEN, THE TIP OF THE TAP BROKE OFF. IT TOOK APPROXIMATELY 60 MINUTES TO REMOVE A FRAGMENT FROM THE PEDICLE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956544 ↗
• MalfunctionMar 1, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TIGHTENER SHAFT BROKE OFF WHILE IN USE AGAINST THE ROBUST PEDICLE WHILE TREATING SCOLIOSIS. A FRAGMENT WAS REMOVED FROM THE LESION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THIRTY(30) MINUTES. THIS REPORT IS FOR ONE (1) VIPER2 6MM SELF DRILLING TAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637249 ↗
• InjuryFeb 13, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A PSF (POSTERIOR SPINAL FUSION) TREATING LUMBAR SPINAL CANAL STENOSIS WAS PERFORMED. WHILE THE TAP (286715600) WAS BEING USED FOR MAKING A BURR HOLE, THE THREADS BROKE OFF IN THE BURR HOLE. THE SURGEON HAD DIFFICULTY REMOVING THE FRAGMENT AND LEFT IT IN THE BURR HOLE. THE PROCEDURE WAS DELAYED BY SIXTY (60) MINUTES. THE SURGEON COMMENTED THAT THE BONE QUALITY WAS ROBUST. THIS REPORT IS FOR ONE (1) VIPER2 6MM SELF DRILLING TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9707705 ↗
• InjuryJul 25, 2019Break; Break

  INTRAOPERATIVELY DURING A VIPER PROCEDURE ONE TAP BROKE AND ANOTHER TAP BENT. THE FRAGMENT OF THE BROKEN TAP REMAINED IN VERTEBRAL BODY OF PATIENT, A VIPER SCREW WAS PLACED NEXT TO IT SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN VIPER SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8826581 ↗
• InjuryAug 14, 2018Break; Break

  ON (B)(6) 2018, THE MIS-PLIF SURGERY FOR LUMBAR SPINAL CANAL STENOSIS WAS PERFORMED BY USING THE VIPER 2 SYSTEM. THE FIXED SITE WAS L5-S. THE FOLLOWING EVENT OCCURRED DURING THE SURGERY. THE SURGEON CREATED 2.6 MM OF PREPARED HOLE USING THE POWER TOOL, AND THEN APPLIED TAPPING BY 6MM USING A GUIDE WIRE. AT THE TIME OF PERFORATING WITH A RATCHET HANDLE, A LARGE NOISE OF ¿CLICK¿ WAS HEARD THROUGHOUT THE OPERATING ROOM. IT WAS FOUND THAT THE LARGE NOISE HAD OCCURRED BECAUSE THE TIP OF THE DRILLING TAP (SUPPOSED TO BE PART#: 286715600) GO BROKEN, AND THE BROKEN TIP WAS ALSO FOUND LEFT BETWEEN THE PATIENT¿S PEDICLE AND VERTEBRAL BODY. CONSIDERING THE PATIENT ON DIALYSIS, THE SURGEON APPLIED THE FOLLOWING PROCEDURES. THE BROKEN TIP OF THE DRILLING TAP WAS NOT EXTRACTED FROM THE PATIENT¿S BODY, BECAUSE THE REMOVAL OF THE BROKEN TIP WOULD LIKELY CAUSE BLEEDING. THE FIXED SITE WAS EXTENDED TO AN UPPER VERTEBRAL BODY TO ENHANCE THE FIXATION. THE SURGERY WAS COMPLETED WITH A 180-MINUTE DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7782297 ↗