VIPER 286725200Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705034214313), received between Jan 29, 2019 and Sep 14, 2021 — classified as 20 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (27 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING PRE-OP FOR A PROCEDURE, THE EXTENSIONS HAD BEEN CRACKED. THE TIP OF THE POLY DRIVER SHAFT WAS BROKEN AND UNABLE TO ENGAGE INTO THE SCREW. ALSO, THE THREADED POST OF THE X25 DRIVER IS NOT STAYING AND CONTINUES TO SLIDE OFF. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470911 ↗
• MalfunctionSep 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING PRE-OP FOR A PROCEDURE, THE EXTENSIONS HAD BEEN CRACKED. THE TIP OF THE POLY DRIVER SHAFT WAS BROKEN AND UNABLE TO ENGAGE INTO THE SCREW. ALSO, THE THREADED POST OF THE X25 DRIVER IS NOT STAYING AND CONTINUES TO SLIDE OFF. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470867 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602799 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602797 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602785 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602784 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602778 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWS KEPT POPPING OFF, AND IT WOULD NOT THREAD CORRECTLY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602770 ↗
• 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 11029647 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR REVISION SURGERY OF SECOND STAGE POSTERIOR FIXATION ON A PREVIOUSLY FIXED L4/S1 ANTERIOR/LATERAL FIXATION WHERE THE L5 WAS SLIPPING. DURING THE SURGERY, SURGEON WAS ATTEMPTING TO FUSE, L4-S2AI POSTERIORLY TO REDUCE /FIXATE SLIP AND DECOMPRESS VIA MIS APPROACH AND CEMENT AUGMENTATION. HOWEVER ONCE REDUCTION FORCES WERE PUT ON THE TOWERS, THE TOWERS LOST GRIP ON THE TOP NOTCH OF THE VIPER 2 CFX SCREWS CAUSING THEM TO DISENGAGE. THIS HAPPENED ON MULTIPLE OCCASIONS (AT LEAST 4 DIFFERENT SCREW EXTENSION TOWERS FAILED DURING PRIMARY ATTEMPTS BUT AT LEAST 4 MORE FAILED IN SUBSEQUENT ATTEMPTS. THE ROD WAS JUST SITTING TOO FAR OFF THE HEAD OF THE SCREW TO BE ABLE TO GET THE REDUCTION INSTRUMENTS TO ENGAGE THERE THREADS AND I DON¿T THINK THAT THE SURGEON WANTED TO REMOVE THE ROD COMPLETELY TO RECONTOUR THE ROD SO THAT IT WOULD. SURGERY WAS SUCCESSFULLY COMPLETED WITH 90 MINUTES DELAY. THE PATIENT WAS RECOVERING FINE AS PER NORMAL RECOVERY TIMELINES WITH NO ADVERSE EFFECT NOTED DUE TO EXTENDED OP TIME, MEDICATION, ANESTHESIA, OR WOUND SIZE (OTHER THAN COSMETIC). CONCOMITANT DEV

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

  MAUDE report 11029641 ↗
• 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 11029582 ↗
• 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 HAP

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

  MAUDE report 11029568 ↗
• 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 11029563 ↗
• 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 NOVEMBER 23, 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 DISENGAGEMEN

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

  MAUDE report 11029542 ↗
• 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 11029464 ↗
• 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 11029462 ↗
• MalfunctionDec 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT THE VIPER 2 MIS CLOSED TOWER DISCONNECTED FROM THE IN-SITU SCREW. TO COMPLETE THE PROCEDURE THE SCREW AND TOWER WERE REPLACED WITH NEW ONES. THERE WERE NO FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWENTY (20) MINUTES. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SCREW EXTENSION, CLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028716 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE VIPER II SYSTEM FAILED, AND IT WAS DIFFICULT TO DETACH THE HEAD. THE SCREWS HAD ALREADY BEEN IMPLANTED, AND WHEN THE SURGEON TRIED TO RE-INCORPORATE THE TOWERS THE INTERNAL FINS OF THE TOWER WERE ANGLED TOWARDS THE CENTER, WHICH PREVENTED THE BAR FROM PASSING. THERE WAS A FORTY (40) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VIPER2 SCREW EXTENSION, CLOSED (PART NUMBER 286725200, LOT UNKNOWN, QUANTITY 1), RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SCREW EXTENSION, CLOSED. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541672 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE VIPER II SYSTEM FAILED, AND IT WAS DIFFICULT TO DETACH THE HEAD. THE SCREWS HAD ALREADY BEEN IMPLANTED, AND WHEN THE SURGEON TRIED TO RE-INCORPORATE THE TOWERS THE INTERNAL FINS OF THE TOWER WERE ANGLED TOWARDS THE CENTER, WHICH PREVENTED THE BAR FROM PASSING. THERE WAS A FORTY (40) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VIPER2 SCREW EXTENSION, CLOSED (PART NUMBER 286725200, LOT UNKNOWN, QUANTITY 1), RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SCREW EXTENSION, CLOSED. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541669 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN MIS PROCEDURE ON A PATIENT WITH TH9 FRACTURE, THREE (3) OF THE SCREW EXTENSION INSTRUMENTS DETACHED FROM THE SCREWS. THE SURGEON WAS UNSUCCESSFUL IN ATTACHING THE EXTENSION ON THE SCREWS WHILE THEY WERE STILL IMPLANTED IN THE PATIENT .THE AFFECTED SCREWS WERE EXPLANTED. THE EXTENSIONS WERE THEN RE-ATTACHED, THE SCREWS RE-IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477044 ↗
• MalfunctionAug 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN MIS PROCEDURE ON A PATIENT WITH TH9 FRACTURE, THREE (3) OF THE SCREW EXTENSION INSTRUMENTS DETACHED FROM THE SCREWS. THE SURGEON WAS UNSUCCESSFUL IN ATTACHING THE EXTENSION ON THE SCREWS WHILE THEY WERE STILL IMPLANTED IN THE PATIENT .THE AFFECTED SCREWS WERE EXPLANTED. THE EXTENSIONS WERE THEN RE-ATTACHED, THE SCREWS RE-IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474568 ↗
• MalfunctionAug 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN MIS PROCEDURE ON A PATIENT WITH TH9 FRACTURE, THREE (3) OF THE SCREW EXTENSION INSTRUMENTS DETACHED FROM THE SCREWS. THE SURGEON WAS UNSUCCESSFUL IN ATTACHING THE EXTENSION ON THE SCREWS WHILE THEY WERE STILL IMPLANTED IN THE PATIENT .THE AFFECTED SCREWS WERE EXPLANTED. THE EXTENSIONS WERE THEN RE-ATTACHED, THE SCREWS RE-IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXTENSION, CLOSED. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474522 ↗
• MalfunctionAug 6, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE RIVET CAME LOOSE AND FELL FROM THE DEVICE WHEN THE TOWER WAS IN-SITU. THE FINAL TIGHTENER WAS THEN REMOVED. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN FINAL TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM SCREW EXTENSION, CLOSED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10374402 ↗
• InjuryFeb 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A SPINAL PROCEDURE WHEN THE SURGEON PLACED THE FIRST VIPERCFX 7X40MM SCREW ON V2 EXTENSION AND POLYAXIAL DRIVER INTO LEFT S1 PEDICLE THE ENTIRE SCREW AND EXTENSION CAME OUT OF THE PEDICLE ONCE THE SCREW WAS INSERTED AND THE PEDICLE REMOVED. WHEN INSERTING THE SECOND 7 X 40MM SCREW INTO THE RIGHT S1 PEDICLE, THE SURGEON THEN TRIED TO REMOVE THE EXTENSION TUBE AND THE TULIP OF THE SCREW COMPLETELY BROKE OFF FROM THE NECK OF THE SCREW. THE SCREW HAD BROKEN IN THE S1 PEDICLE. A SCREW REMOVAL KIT WAS USED TO REMOVE THE SHANK OF THE BROKEN SCREW. THIS WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED BY UPSIZING TO AN 8X50MM SCREW. THERE WAS A SIXTY (60) MINUTE DELAY. IT WAS NOTED NO FRAGMENTS WERE GENERATED AND THE SCREWS WERE EASILY REMOVED. IT WAS NOTED THERE WAS NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE: SCREWDRIVER (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A V2 EXTENSION. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9676062 ↗
• InjuryDec 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9468810 ↗