VIPER 186727650Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034282572), received between Jun 21, 2018 and Jan 8, 2024 — classified as 2 deaths, 10 injuries, 6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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: NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER ,EXPEDIUM POLYAXIAL AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18466788 ↗
• InjuryJan 4, 2024Migration; Migration

  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: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL AND VIPER CFX FENESTRATED PRODUCTS (MIS TI CFX FEN POLY 6X50 FOR (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Osteolysis; Unspecified Infection

  MAUDE report 18443227 ↗
• InjurySep 22, 2023Device Slipped; Adverse Event Without Identified Device or Use Problem; Device Slipped; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT INVOLVES ONE MIS TI CFX FEN POLY 6X50. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 17799013 ↗
• InjuryMay 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON AN UNKNOWN DATE IN 2016 TO TREAT A FRACTURE. ON (B)(6) 2023, THREE SCREWS WERE FOUND TO BE BROKEN. THE SURGEON STATED THAT THEY BROKE DUE TO BEING IN THE PATIENT FOR TOO LONG AND THAT THEY SHOULD HAVE BEEN REMOVED 12 MONTHS POSTOPERATIVELY. THE METALWARE WAS REMOVED, AND BROKEN SCREW SHAFTS REMAINED THE PATIENT. NOTHING NEW WAS IMPLANTED; THE GOAL OF THE ORIGINAL FIXATION HAD BEEN ACHIEVED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 50MM THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16852753 ↗
• MalfunctionMar 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING PRE-SURGERY PREPARATION THE POLYAXIAL HEAD OF THE SCREW WAS LOOSENING FROM THE SCREW BODY. NO SURGICAL IMPACT REPORTED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667536 ↗
• InjuryFeb 8, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN IMPLANT REMOVAL SURGERY ON (B)(6) 2022, WHILE UNSCREWING THE SCREWS ON L5, THE SURGEON NOTICED THAT THE SCREWS WERE BROKEN. SURGEON REMOVED THE TULIPS; HOWEVER THE BODY OF THE SCREWS REMAINED IN THE PEDUNCLES. THE PATIENT WAS INITIALLY OPERATED 5 YEARS AGO IN 2018 WITH L4-L5 STABILIZATION FOR L4 / L5 STENOSIS AND INSTABILITY. SUBSEQUENTLY LATER ON (B)(6) 2019 THE SYSTEM WAS LENGTHENED ON L3 FOR L3 JUNCTIONAL PATHOLOGY WITH REPLACEMENT OF THE L4 LEFT SCREW AS IT WAS MOBILIZED. THE REPLACED SCREW OF L4 WAS A 7X50 EXPEDIUM SCREW. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 6X50. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 13487447 ↗
• InjuryFeb 8, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN IMPLANT REMOVAL SURGERY ON (B)(6) 2022, WHILE UNSCREWING THE SCREWS ON L5, THE SURGEON NOTICED THAT THE SCREWS WERE BROKEN. SURGEON REMOVED THE TULIPS; HOWEVER THE BODY OF THE SCREWS REMAINED IN THE PEDUNCLES. THE PATIENT WAS INITIALLY OPERATED 5 YEARS AGO IN 2018 WITH L4-L5 STABILIZATION FOR L4 / L5 STENOSIS AND INSTABILITY. SUBSEQUENTLY LATER ON (B)(6) 2019 THE SYSTEM WAS LENGTHENED ON L3 FOR L3 JUNCTIONAL PATHOLOGY WITH REPLACEMENT OF THE L4 LEFT SCREW AS IT WAS MOBILIZED. THE REPLACED SCREW OF L4 WAS A 7X50 EXPEDIUM SCREW. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 6X50. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 13487217 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM AUSTRALIA 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 FLOUROSCOPY. 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. THE DISENGAGEMENT HAPP

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

  MAUDE report 11029599 ↗
• MalfunctionSep 3, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, IT WAS DISCOVERED THAT THE THREAD OF THE SCREW WAS DEFECTIVE. THE SCREW WAS INSERTED AND IN SITU, WHEN TRYING TO TIGHTEN THE INNIE, IT WAS FOUND THAT THE THREAD WAS DEFECTIVE. THE SCREW WAS TAKEN OUT AND REPLACED WITH ANOTHER ONE. NO SIGNIFICANT SURGICAL DELAY NOR PATIENT HARM REPORTED. THIS REPORT IS FOR A VIPER CORTICAL FIX FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10490349 ↗
• InjuryDec 2, 2019Migration; Migration

  3 WEEKS POST OP IT WAS OBSERVED AN BIPER INNER SET SCREW LOOSENING ON THE X-RAY, THE SET SCREW WAS LOST FROM THE SCREW AND THE CONSTRUCT NEEDED TO BE REVISED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Code Available

  MAUDE report 9396644 ↗
• MalfunctionSep 13, 2019Break; Break

  INTRAOPERATIVELY WHEN SCREWING THE INNIE INTO THE CFX SCREW THE SCREW FRACTURED INTO IT´S THREE SINGLE COMPONENTS. NO SURGERY DELAY REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9029371 ↗
• InjuryAug 20, 2019Break; Break

  SALES REP IS REPORTING A REVISION / EXPLANTATION OF CFX SCREWS BECAUSE OF UNKNOWN REASON. DOI: UNKNOWN, DOR: (B)(6) 2019. NO SURGERY DELAY. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8910555 ↗
• InjuryAug 20, 2019Break; Break

  SALES REP IS REPORTING A REVISION / EXPLANTATION OF CFX SCREWS BECAUSE OF UNKNOWN REASON. DOI: UNKNOWN, DOR: (B)(6) 2019. NO SURGERY DELAY. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8910405 ↗
• MalfunctionJun 7, 2019Disconnection; Disconnection

  THE SCREWS WERE PLACED PERCUTANEOUS AND MINI OPEN IN L5 AND S1. THE ANATOMICAL SITUATION OF THE SCREWS TO EACH OTHER WAS VERY CLOSE. WHEN THE STAFF REDUCTION WITH THE SO-CALLED VIPER 3D: THE INNER RINGS HAVE BECOME / BLOCKING RINGS IN THE CFX SCREW LOOSENED. SO THAT THE ROD REPOSITION WITH LOCKING OF THE INNIE COULD NOT TAKE PLACE. THE TWO SCREWS HAD TO BE REMOVED AND BOTH SCREWS ARE EXCHANGED AND NEW PLACES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679707 ↗
• MalfunctionJun 7, 2019Disconnection; Disconnection

  THE SCREWS WERE PLACED PERCUTANEOUS AND MINI OPEN IN L5 AND S1. THE ANATOMICAL SITUATION OF THE SCREWS TO EACH OTHER WAS VERY CLOSE. WHEN THE STAFF REDUCTION WITH THE SO-CALLED VIPER 3D: THE INNER RINGS HAVE BECOME / BLOCKING RINGS IN THE CFX SCREW LOOSENED. SO THAT THE ROD REPOSITION WITH LOCKING OF THE INNIE COULD NOT TAKE PLACE. THE TWO SCREWS HAD TO BE REMOVED AND BOTH SCREWS ARE EXCHANGED AND NEW PLACES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679620 ↗
• 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), 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 (12) VIPER SCREWS/INNIES, 2 TITANIUM RODS, 3 CONFIDENCE CEMENTS. OPERATING ROOM (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 7655444 ↗
• 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/ 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 7654647 ↗
• MalfunctionJun 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INNER PART OF THE CFX SCREW HEAD 1867-27-650 (6X50) LOOKS LIKE IT IS TURNED SO THAT YOU CANNOT BRING IN THE ROD

  Patient problems: Not Applicable

  MAUDE report 7626060 ↗