VIPER 186789300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034133164), received between Jul 2, 2018 and Apr 27, 2023 — classified as 2 deaths, 4 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE SURGERY TO IMPLANT THE RODS ON AN UNKNOWN DATE. AFTER SURGERY, THE RODS WERE FOUND TO BE BROKEN. NON-UNION HAD OCCURRED. REOPERATION WILL BE PERFORMED, OR WAS ALREADY PERFORMED, ON AN UNKNOWN DATE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, STRAIGHT 300MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16822921 ↗
• InjuryApr 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE SURGERY TO IMPLANT THE RODS ON AN UNKNOWN DATE. AFTER SURGERY, THE RODS WERE FOUND TO BE BROKEN. NON-UNION HAD OCCURRED. REOPERATION WILL BE PERFORMED, OR WAS ALREADY PERFORMED, ON AN UNKNOWN DATE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, STRAIGHT 300MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16822919 ↗
• MalfunctionJul 1, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, WHEN THE SURGEON HELD THE ROD IN QUESTION WITH A ROD HOLDER, IT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT ROD. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD, STRAIGHT 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885709 ↗
• InjuryMay 27, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A PRIMARY SPINAL FUSION TREATING TUMOR. ON AN UNKNOWN DATE IT WAS FOUND THAT THE ROD WHICH WAS DEPLOYED AT T11 LOWER LEFT HAD BROKEN OFF. THE PATIENT IS EXPECTED TO UNDERGO A REVISION PROCEDURE IN MAY. IT WAS NOTED, THE BONE GRAFT WAS ORIGINALLY APPLIED IN THE LESION. HOWEVER, BONE FUSION HAD WAS NOT COMPLETED, WHICH MIGHT HAVE TRIGGERED THE EVENT. THIS REPORT IS FOR A ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11895031 ↗
• InjuryJan 3, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WITH A BROKEN ROD. SHE HAS HAD 4 PREVIOUS SURGERIES FOR NON-UNIONS WITH HER LUMBAR FUSION. THE BROKEN ROD SPANNED A SEGMENT WHICH HAD NO INTERBODY DEVICE SPANNING FROM T10 - L4 WHICH THEN LINKED INTO A SEPARATE CONSTRUCT DOWN TO THE PELVIS.

  Patient problems: No Code Available

  MAUDE report 8213779 ↗
• DeathJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). DURING THE SURGERY WITH VIPER 2 SYSTEM, THE PATIENT WENT INTO THE CARDIAC ARREST, FOLLOWED BY THE REANIMATION THAT WAS NOT SUCCESSFUL. THE PATIENT WAS AN OLDER FEMALE, (B)(6), WITH BECHTEREW DISEASE. THE SURGERY WAS ALMOST FINISHED AT THE TIME OF THE EVENT, WITH ALL THE SCREWS INSERTED AND FINISHED VERTEBROPLASTY IN 6 VERTEBRAL BODIES. THE 12 VIPER SCREWS/INNIES, 2 TITANIUM RODS, 3 CONFIDENCE CEMENTS. OR DOCTOR PROVIDED A MEDICAL RATIONALE THAT INDICATES THE USE OF THE PRODUCT IS IN NO WAY RELATED TO THE REPORTED EVENT: THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS THAT COULD POTENTIALLY RESULT IN THE OUTCOME.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7655491 ↗
• DeathJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTER: (B)(6). DURING THE SURGERY WITH VIPER 2 SYSTEM, THE PATIENT WENT INTO THE CARDIAC ARREST, FOLLOWED BY THE REANIMATION THAT WAS NOT SUCCESSFUL. THE PATIENT WAS AN OLDER FEMALE, (B)(6) YEARS OLD, WITH BECHTEREW DISEASE. THE SURGERY WAS ALMOST FINISHED AT THE TIME OF THE EVENT, WITH ALL THE SCREWS INSERTED AND FINISHED VERTEBROPLASTY IN 6 VERTEBRAL BODIES. TWELVE VIPER SCREWS/INNIES, 2 TITANIUM RODS, 3 CONFIDENCE CEMENTS. OPERATING ROOM DOCTOR PROVIDED A MEDICAL RATIONALE THAT INDICATES THE USE OF THE PRODUCT IS IN NO WAY RELATED TO THE REPORTED EVENT: THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS THAT COULD POTENTIALLY RESULT IN THE OUTCOME.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7654714 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467