VIPER 186727645Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034282565), received between Dec 1, 2017 and Oct 25, 2024 — classified as 3 deaths, 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE REVISION SURGERY TLIF L3-S1 WAS PERFORMED BECAUSE PATIENT LEFT AND RIGHT S1 PEDICLE SCREWS BROKE. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 20538435 ↗
• InjuryOct 25, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE REVISION SURGERY TLIF L3-S1 WAS PERFORMED BECAUSE PATIENT LEFT AND RIGHT S1 PEDICLE SCREWS BROKE. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 20536779 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130601 ↗
• MalfunctionMay 6, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED INTRA-OPERATIVELY THE PEDIATRICIAN HAD DIFFICULTY INSERTING A SCREW SO THEY DISCARDED IT. ANOTHER SCREW WAS USED AND WAS ABLE TO BE INSERTED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THIS REPORT IS FOR A SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249221 ↗
• MalfunctionApr 4, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024 SURGEON HAD A PROBLEM INSERTING A CFX EXPEDIUM SCREW. THEREFORE ANOTHER SCREW WAS USED AND INSERTED CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047125 ↗
• MalfunctionFeb 14, 2024Crack; Difficult to Advance; Crack; Difficult to Advance

  DEVICE REPORT FROM SPAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE WITH THE CORTICAL FIXATION SCREW IN QUESTION. AS THE CORE OF THE SCREW WAS TURNED, THE SURGEON WAS UNABLE TO REDUCE THE ROD BECAUSE IT STOPPED. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER ONE OF THE SAME TYPE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10 MINUTES. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702715 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: INSTABILITY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER ,MOSS MIAMI SI /OTHER, VIPER CFX FENESTRATED AND VIPER INSTRUMENTS PRODUCTS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18464824 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SPAIN REPORTS AN EVENT AS FOLLOWS:IT WAS REPORTED THAT ON AN UNKNOWN DATE IN JANUARY OF 2023, THE PATIENT UNDERWENT AN OPERATION WITH THE PRODUCTS IN QUESTION. THE PATIENT¿S RADICULAR PAIN IMPROVED AFTER THE SURGERY, BUT THEY HAVE SINCE HAD DISABLING LUMBAR PAIN. TESTS PERFORMED WITH X-RAY AND CT SCAN WERE NORMAL. THE PATIENT SUSPECTS THEY HAVE AN ALLERGY TO TITANIUM. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM.THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18278274 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SPAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN JANUARY OF 2023, THE PATIENT UNDERWENT AN OPERATION WITH THE PRODUCTS IN QUESTION. THE PATIENT¿S RADICULAR PAIN IMPROVED AFTER THE SURGERY, BUT THEY HAVE SINCE HAD DISABLING LUMBAR PAIN. TESTS PERFORMED WITH X-RAY AND CT SCAN WERE NORMAL. THE PATIENT SUSPECTS THEY HAVE AN ALLERGY TO TITANIUM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18277342 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SPAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN JANUARY OF 2023, THE PATIENT UNDERWENT AN OPERATION WITH THE PRODUCTS IN QUESTION. THE PATIENT¿S RADICULAR PAIN IMPROVED AFTER THE SURGERY, BUT THEY HAVE SINCE HAD DISABLING LUMBAR PAIN. TESTS PERFORMED WITH X-RAY AND CT SCAN WERE NORMAL. THE PATIENT SUSPECTS THEY HAVE AN ALLERGY TO TITANIUM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18277340 ↗
• MalfunctionApr 4, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED THE CUSTOMER RECEIVED A DAMAGED IMPLANT. DISTRIBUTION CENTER CONFIRMED THAT NOTHING HAPPENED IN SHIPPING OR IN DISTRIBUTION CENTER. NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN DAMAGE OCCURRED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR MIS TI CFX FEN POLY 6X45.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677400 ↗
• MalfunctionMar 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, BOTH THE SETSCREW AND THE SCREW TULIP WERE DAMAGED DURING THE FINAL LOCKING PROCESS. BOTH IMPLANTS HAD TO BE REPLACED. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805034 ↗
• DeathOct 14, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12635774 ↗
• MalfunctionJun 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE CANNULATED RATCHETING ADAPTER BROKE. NO FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER TRAY OF INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT OUTCOME WAS GOOD. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957344 ↗
• InjuryMar 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE, THE EXPEDIUM SI 6X45MM SCREW BROKE. THE FRACTURE POINT OF THE SCREW WAS DIRECTLY BELOW THE SCREW HEAD, AT THE TRANSITION TO THE SCREW SHAFT. THE PARAVERTEBRAL RODS WERE NOT BROKEN. THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2020, WITH A SCREW AND ROD CONSTRUCT ON THE LUMBAR SPINE. ON (B)(6) 2021, AS PART OF A REVISION SPONDYLODESIS, THE BROKEN SCREW IS REPLACED WITH A NEW SCREW. ALL FRAGMENTS WERE EASILY REMOVED. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11588317 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SECOND STAGE POSTERIOR FIXATION ON A PREVIOUSLY FIXED L4/5/S1 ANTERIOR/LATERAL FIXATION WHERE THE PATIENTS L5 WAS SLIPPING, THE SURGEON WAS FUSING THE L4-S2AI POSTERIORLY TO REDUCE/FIXATE SLIP AND DECOMPRESS VIA A MINIMALLY INVASIVE SURGERY (MIS) APPROACH WITH CEMENT AUGMENTATION. THE APPROACH WAS TO USE VIPER 2 CFX SCREWS L4-S1 AND THEN VIPER SAI SCREWS INTO SACRAL ILIAC PERCUTANEOUSLY WITH THE AIM TO FURTHER ENHANCE THE FIXATION WITH CEMENT AUGMENTATION L4-S1. THE PEDICLES WERE SUCCESSFULLY TARGETED USING BRAINLAB NAVIGATION AND AUGMENTED SCREWS USING CONFIDENCE CEMENT UNDER FLUOROSCOPY. THE ROD WAS INSERTED VIA THE VIPER 2 EXTENSIONS SUCCESSFULLY. DURING THE REDUCTION OF THE ROD INTO THE HEADS OF THE SCREWS USING THE VIPER 3D REDUCTION INSTRUMENTS, THE TOWERS LOST GRIP ON THE TOP NOTCH OF THE VIPER 2 CFX SCREWS CAUSING THEM TO DISENGAGE ONCE REDUCTION FORCES WERE PUT ON THE TOWERS. THIS HAPPENED ON MULTIPLE OCCASIONS, AT LEAST FOUR (4) DIFFERENT SCREW EXTENSION TOWERS FAILED DURING PRIMARY ATTEMPTS AND AT LEAST FOUR (4) MORE FAILED IN SUBSEQUENT ATTEMPTS. SURGEON WAS FORCED TO CON

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 11029638 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR L5-S1 TLIF PROCEDURE. IT WAS DISCOVERED THAT TPAL SET WERE DELIVERED WITHOUT THE APPLICATOR INSTRUMENTS. IT WAS UNKNOWN WHEN DISCOVERED THAT THE APPLICATOR SHAFT IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. THE PATIENT HAS INFECTION AND PAIN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10786221 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR L5-S1 TLIF PROCEDURE. IT WAS DISCOVERED THAT TPAL SET WERE DELIVERED WITHOUT THE APPLICATOR INSTRUMENTS. IT WAS UNKNOWN WHEN DISCOVERED THAT THE APPLICATOR SHAFT IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. THE PATIENT HAS INFECTION AND PAIN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10786220 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR L5-S1 TLIF PROCEDURE. IT WAS DISCOVERED THAT TPAL SET WERE DELIVERED WITHOUT THE APPLICATOR INSTRUMENTS. IT WAS UNKNOWN WHEN DISCOVERED THAT THE APPLICATOR SHAFT IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. THE PATIENT HAS INFECTION AND PAIN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10786208 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR L5-S1 TLIF PROCEDURE. IT WAS DISCOVERED THAT TPAL SET WERE DELIVERED WITHOUT THE APPLICATOR INSTRUMENTS. IT WAS UNKNOWN WHEN DISCOVERED THAT THE APPLICATOR SHAFT IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. THE PATIENT HAS INFECTION AND PAIN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 6X45. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10786204 ↗
• InjuryNov 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIGINAL L5/S1 FUSION SURGERY ON (B)(6) 2017. ON AN UNKNOWN POSTOPERATIVE DATE S1 SCREWS FRACTURED AND L5 SCREWS LOOSENED, WHICH RESULTED IN NEED FOR REVISION PROCEDURE ON (B)(6) 2019 TO REMOVE BROKEN SCREWS AND REVISE BOTH L5 AND S1 SCREWS DUE TO PAIN AND DYSFUNCTION. THIS WAS A PLANNED REVISION SURGERY. THERE WAS SURGICAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES TO REMOVE BROKEN SCREWS. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9371418 ↗
• MalfunctionNov 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WE WANTED TO FIX A CFX 6X45 SCREW ON THE SCREWDRIVER BUT THE INTERNAL PART IN THE SCREW HEAD WAS MOBILIZED AND IMPOSSIBLE TO PUT THE SCREW PROPERLY IN THE VERTEBRAL BODY WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10 MINUTES. ACTION TAKEN WHEN EVENT OCCURRED? CHANGED THE SCREW. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. 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: NO. IP (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9266315 ↗
• MalfunctionSep 4, 2018Disconnection; Disconnection

  INTRAOPERATIVELY THE POLYAXIAL SCREW HEADS WERE FIXED. NO ADVERSE CONSEQUENCES FOR PATIENT, NO SURGERY DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843230 ↗
• MalfunctionAug 8, 2018Break; Break

  UNKNOWN DEFECT OF SCREW, UPDATE WILL FOLLOWING. ON (B)(6) 2018 CLARIFICATION RECEIVED FROM LOC: DURING IMPLANTATION THE SCREW 1ST DISCONNECTED IN 2 PIECES. THE INNER RING FOR FIXING THE SCREW-SHANK WAS IN THE X-RAY SEPARATELY AND THE SCREW HAD TO BE CHANGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761964 ↗
• 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 7655417 ↗