VIPER 186727640Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034282558), received between Mar 20, 2018 and Dec 16, 2025 — classified as 2 deaths, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.

  Patient problems: Pain

  MAUDE report 23823898 ↗
• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.

  Patient problems: Pain

  MAUDE report 23823897 ↗
• 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 (B)(6) 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 40MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18277374 ↗
• 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 (B)(6) 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 40MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18277344 ↗
• 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 (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 (1) MIS TI CFX FEN POLY 6X40. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957351 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: THE THREAD OF THE SCREW WAS TURNED OFF BY THE PERSUADER OF THE VIPER SYSTEM. THE INNER SET SCREW COULD NOT FIND ANY THREAD TO LOCK INTO. THE SCREW AND THE INNER WERE BOTH REPLACED WITH NEW DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. DURING THE MANUFACTURER INVESTIGATION OF THE RETURNED PRODUCT IT WAS NOTED THAT HEAD'S THREADS ARE TORN OFF. THIS REPORT IS FOR A SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215178 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  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 11029561 ↗
• InjuryMay 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8620869 ↗
• 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 7655071 ↗
• 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. 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 7654585 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  THE PATIENT RETURNED TO CLINIC WITH DR. (B)(6) COMPLAINING OF PAIN ORIGINATING AT T7-T8 AND T8-T9. THE PATIENT HAD BEEN PREVIOUSLY BEEN OPERATED ON BY DR. (B)(6) FOR KYPHOSIS (DATE UNKNOWN) T9-ILIUM. DR. (B)(6) SCHEDULED SURGERY FOR THE PATIENT ON (B)(6) 2018 AND PLANNED TO EXTEND THE CONSTRUCT TO T3-T9 FROM THE PREVISOU T9-ILIUM AND DECOMPRESS T7-T9 TO TREAT THE ADJACENT LEVEL DEGENERATION THAT WAS EVIDENT FROM CLINICAL EVALUATION AND RADIOGRAPHIC CONFIRMATION. UPON SURGERY, DR. (B)(6) SUCCESSFULLY PLACED VIPER CORTICAL FIX FENESTRATED SCREWS FROM T3-T8 (RIGHT) AND T3-T9 (LEFT). DR. (B)(6) REMOVED THE PREVIOUS T9 SCREWS/REPLACED THE T9/LEFT FOR CONSTRUCT ROD ATTACHMENT. DR. (B)(6) USED A TITANIUM EXPEDIUM INLINE ROD (5.5/6.35-5.5MM ON THE RIGHT THAT SPANNED FROM T3-T9. DR. (B)(6) USED A TITANIUM EXPEDIUM BIASED Z-ROD ON THE LEFT IN CONJUNCTION WITH AN EXPEDIUM SIDE BY SIDE FOUR SET SCREW CONNECTOR TO CONNECT THE PREVIOUS CONSTRUCT TO THE NEW SCREWS FROM T3-T8. DR. (B)(6) SUCCESSFULLY FINAL TIGHTENED THE SET SCREW ON THE RIGHT (INLINE ROD) AND THEN PROCEEDED TO FINAL TIGHTEN THE SET SCREWS ON THE LEFT (Z-ROD). UPON TIGHTENING THE T9 SET SCREW ON THE LEFT (VIPER CORTICAL FIX FENESTR

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7353580 ↗