VIPER 186727750Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705034282688), received between Feb 14, 2018 and Sep 29, 2026 — classified as 14 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936669 ↗
• MalfunctionJul 7, 2025Compatibility Problem; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED: " THE GRUB SCREW IN THE TULIP OF THE LWK4 SCREW ON THE LEFT COULD NOT BE FIXED, IT TURNED THROUGH AND I DID NOT LET IT BE TIGHTENED AND TURNED BACK UP. SO I HAD TO BREAK IT OUT OF THE TULIP WITH FORCE. THEN A SCREW CHANGE TOOK PLACE, SINCE THE THREAD FOR THE SET SCREW WAS NO LONGER SAFELY INTACT AND THEN FINALLY THE ROD COULD BE FIXED WITH A NEW INNIE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411239 ↗
• InjuryJun 16, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE TWO SCREWS NOT BEING STRONG ENOUGH. THEY REMOVED THE BOLT HEAD FROM THE SPINDLE. IT HAPPENED ABOUT A MONTH AFTER THE PROCEDURE. SURGERY REVISION, PHYSICIAN USED BIGGER SCREWS. THE REVISION SURGERY WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 22210637 ↗
• InjuryJun 16, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE TWO SCREWS NOT BEING STRONG ENOUGH. THEY REMOVED THE BOLT HEAD FROM THE SPINDLE. IT HAPPENED ABOUT A MONTH AFTER THE PROCEDURE. SURGERY REVISION, PHYSICIAN USED BIGGER SCREWS. THE REVISION SURGERY WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 22210619 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT THE HEAD OF THE SCREW WAS REMOVING FROM THE SPINDLE WHEN IT WAS BEING SCREWED. THE PHYSICIAN USED ANOTHER PRODUCT. THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620124 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT IT WAS NECESSARY TO UNSCREW THE SCREWS BECAUSE THE HEAD OF THE SCREW BROKE WHILE SCREWING IT IN. THERE WAS NO SEALING ON THE CEMENT DELIVERY PUMP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374044 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT IT WAS NECESSARY TO UNSCREW THE SCREWS BECAUSE THE HEAD OF THE SCREW BROKE WHILE SCREWING IT IN. THERE WAS NO SEALING ON THE CEMENT DELIVERY PUMP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374009 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT IT WAS NECESSARY TO UNSCREW THE SCREWS BECAUSE THE HEAD OF THE SCREW BROKE WHILE SCREWING IT IN. THERE WAS NO SEALING ON THE CEMENT DELIVERY PUMP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373872 ↗
• InjuryJul 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT HAS THE SCREW IN BODY AND RECEIVED A ONE ADDITIONAL LEVEL OF FUSION. SURGERY WAS FINISHED AND PATIENT ALIVE AND NO OTHER ADVERSE EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794193 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT ON MAY 15, 2024 WHILE PLACING A ROD ON THE LEFT SIDE L4 PEDICLE SCREW THE BUSHING OF THE SCREW BROKE. THE BROKEN PEDICLE SCREW WAS REMOVED AND NEW ONE WAS IMPLANTED WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 7X50THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-001610586

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510691 ↗
• 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: FRACTURE VERTEBRAL STRUCTURES, WOUND HEALING PROBLEM COMPLICATION TIME/INTERVENTION INTRAOPERATIVE, REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM, VIPER /OTHER, VIPER CFX FENESTRATED AND VIPER INSTRUMENTS PRODUCTS THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 18464042 ↗
• 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: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (MIS TI CFX FEN POLY 7X50 (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18463721 ↗
• 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: WOUND INFECTION DEEP, POSTOPERATIVE INFECTION DEEP, POSTOPERATIVE INFECTION SUPERFICIAL COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (MIS TI CFX FEN POLY 7X50 (B)(4).

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18463336 ↗
• InjuryJan 5, 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: CEREBRAL, WOUND INFECTION SUPERFICIAL, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM COMPLICATION TIME/INTERVENTION POSTOPERATIVE (BEFORE DISCHARGE) THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 7X50 THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18458858 ↗
• InjuryJan 5, 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: DURAL LESION, ADJACENT SEGMENT PATHOLOGY, NEUROCOMPRESSION . COMPLICATION TIME/INTERVENTION. INTRAOPERATIVE, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis; Unspecified Tissue Injury

  MAUDE report 18454577 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON TAPPED THE VERTEBRAE PEDICLE WITH A 6MM EXPEDIUM TAP AS REQUESTED. THE SURGEON ENCOUNTERED DENSE, HARD BONE AND HAD TO EXHIBIT FOR ON THE TAP TO PENETRATE THE PEDICLE AND VERTEBRAL BODIES OF ALL DESIRED LEVELS. THE REP ASKED THE SURGEON IF HE WOULD LIKE TO USE THE 7MM TAP AS OPPOSED TO UNDERSIZING THE TAP FOR A 7MM PEDICLE SCREW. THE SURGEON ATTEMPTED TO PUT A 7MM DIAMETER VIPER CORTICAL FIX PEDICLE SCREW IN T11 ON THE LEFT. THE SURGEON BEGAN TO ENCOUNTER RESISTANCE AS THE SCREW ONLY BURIED HALFWAY THROUGH ITS LENGTH. THE SURGEON HEARD A SNAP. HE REMOVED THE SCREWDRIVER (3010-19-003) FROM THE PEDICLE SCREW AND NOTICED THE TIP OF THE SCREWDRIVER HAD SHEARED OFF. THE SURGEON SUCCESSFULLY REMOVED THE BROKEN PIECE OF THE SCREWDRIVER. THE SURGEON THEN TOOK ANOTHER PEDICLE SCREWDRIVER (2797-12-400) AND ATTEMPTED TO INSERT THE SCREW. THE TIP OF THE SCREW BROKE ON THE 2ND ATTEMPT WITH THE NEW SCREWDRIVER. THE SURGEON THEN REMOVED THE BROKEN SCREWDRIVER AND THE 7MM SCREW. HE TAPPED WITH A 7MM TAP AND INSERTED A NEW SCREW SUCCESSFULLY. 15 MINUTES SURGICAL DELAY REPORTED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132456 ↗
• MalfunctionAug 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING A DORSAL STABILIZATION SURGERY AFTER LUMBAR XLIF FITTING ON (B)(4) 2023, DURING THE LAST TURNS OF THE CFX, THE SCREW SHAFT BROKE BELOW THE TULIP. ALSO, THE TIP OF THE SCREWDRIVER BROKE OFF DURING THE LAST ROTATION. THE BROKEN SCREW SHAFT REMAINED IN THE PATIENT, SO IT COULD ONLY BE STABILIZED ON THE OPPOSITE SIDE. THE SURGERY WAS DELAYED BY APPROXIMATELY 10 MINUTES, BUT COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM. IT WAS NOTED THAT THE PATIENT HAD VERY SCLEROTIC BONE. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587069 ↗
• InjuryAug 17, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE S1 SCREWS IN QUESTION HAD FRACTURED INSIDE OF THE PATIENT. REVISION PROCEDURE WAS PERFORMED ON UNKNOWN DATE IN 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17564102 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, HE HAS SEEN AN INCREASE OF S1 SCREWS FRACTURING IN HIS PATIENTS. THESE SCREWS WERE IMPLANTED IN HIS PATIENTS 1-2 YEARS AGO. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50M. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17563905 ↗
• InjuryJul 28, 2023Break; Device Slipped; Break; Device Slipped

  (B)(6) 2022 (IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW DURING THE PROCEDURE ON (B)(6) 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED AS A DECREASE OF PAIN MEDICATION AND A DISCHARGE TO CONTEMPORARY NURSERY HOME NO FURTHER FOLLOW UP FOR THIS COMPLAINT WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON PC-001389641. THE REPORTED SCREWS HAD MALFUNCTIONS DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412415 ↗
• InjuryJul 28, 2023Break; Device Slipped; Break; Device Slipped

  (B)(6) 2022 (IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW DURING THE PROCEDURE ON (B)(6) 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED AS A DECREASE OF PAIN MEDICATION AND A DISCHARGE TO CONTEMPORARY NURSERY HOME NO FURTHER FOLLOW UP FOR THIS COMPLAINT WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON (B)(4). THE REPORTED SCREWS HAD MALFUNCTIONS DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412414 ↗
• MalfunctionJul 10, 2023Device Slipped; Device Slipped

  THE OPERATION WAS A SPINOPELVIC STABILIZATION PROCEDURE WITH CFX SCREWS. AFTER INSERTING THE ROD INTO THE SCREW HEADS, THE SURGEON ATTEMPTED TO FIX IT WITH SET SCREWS AND THE MONO-INNIE TIGHTENED WITHOUT PROBLEMS. HOWEVER, WHEN RETIGHTENING WITH THE TORQUE LIMITER THE INNIE OVERTIGHTENED, LEAVING IT LOOSE AGAIN. THE SURGEON CHANGED TO THE ILIUM SCREW BECAUSE THE SCREW HEAD WAS NO LONGER STABLE. IT WAS REATTEMPTED WITH A NEW CFX SCREW BUT THE SAME RESULT OCCURRED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING AN EXPEDIUM POLYAXIAL SCREW WITH A DOUBLE INNIE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286746 ↗
• MalfunctionApr 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: CUSTOMER REPORTED- IT WAS REPORTED ON (B)(6) 2023, THAT INTRAOPERATIVELY, THE TULIP HAS DETACHED FROM THE SCREW. THE INNER MECHANISM IS BROKEN. SURGERY DELAY TIME 20 MIN. SURGERY WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED AND THE SCREW SHAFT REMAINED IN THE PATIENT. PATIENT OUTCOME IS GOOD. NO PATIENT INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 7X50. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785501 ↗
• MalfunctionDec 28, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AN OSTEOPOROTIC PATIENT UNDERWENT FOR CEMENT AUGMENTATION. THIS WAS AN MIS PROCEDURE AND VCFFS SCREWS USED. DURING SCREW INSERTION, 2-SCREW HEAD BRAKED AND COME OUT ON ALIGNMENT SLEEVE, WHEREAS SCREW SHANK WAS IN THE VERTEBRAL BODY ITSELF. THERE WAS ISSUE IN INNIE (LOCKING CAP) INSERTION INITIALLY AND INNIES THREADS WERE NOT ENGAGING TO THE SCREW, AND WHEN SURGEON TRIED TO REVISE THE SCREW, BOTH THE HEADS ONLY CAME OUT. TOTAL 2 SCREWS AND 4 INNIES DAMAGED. WITHOUT REMOVING FRAGMENTS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 60-MINUTES DELAY. THE PATIENT CONSEQUENCES WERE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 7X50. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101130 ↗
• MalfunctionAug 21, 2020Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE TIP OF THE SCREWDRIVER BROKE OFF AND WAS STUCK IN THE HEAD OF THE SCREW. THE SCREW HAD TO BE CHANGED BECAUSE IT HAD NOT BEEN TIGHTENED ENOUGH. TO REMOVE THE SCREW, AN EXPEDIUM ROD WITH AN EXPEDIUM INNIE WITH TORQUE WAS CONNECTED TO THE SCREW WHICH WAS THEN REMOVED WITH A ROTATION STABILIZER. THE SCREW WAS REMOVED AND A NEW SCREW WAS IMPLANTED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL SCREW DRIVER T20. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437918 ↗