VIPER PRIME 186760445Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034509402), received between Mar 15, 2018 and Sep 4, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS IDENTIFIED BEFORE THE CASE THAT THREE SCREWS HAD BROKEN POSTOPERATIVELY IN THE PATIENT. TWO VIPER PRIME CFXFEN XTAB 5X45MM BROKE AT THE T12 LEVEL AND ONE VIPER PRIME CFXFEN XTAB 6X45MM BROKE AT THE L2 LEVEL ON THE LEFT. ALL SCREWS WERE REMOVED. THE THREE BROKEN SCREWS WERE MOSTLY REMOVED, BUT FRAGMENTS WERE LEFT IN THE VERTEBRAE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20133938 ↗
• InjuryMar 12, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED THAT A PROCEDURE OF LUMBAR ARTHRODESIS WAS PERFORMED ON A PATIENT. AFTER 10 MONTHS OF THE PROCEDURE, THE PATIENT CAME INTO CONTACT WITH THE DOCTOR COMPLAINING OF STRONG LUMBAR PAIN, WITH IRRADIATION TO THE LEFT LOWER LIMB AND PARESTHESIA ASSOCIATED WITH IMPORTANT FUNCTIONAL LIMITATION, WITH DIFFICULTY PERFORMING DAILY WORK ACTIVITIES. CLINICAL AND RADIOLOGICAL TESTS WERE PERFORMED AND PROVED THE SCREW BREAKAGE. A NEW PROCEDURE WAS CARRIED OUT FOR REMOVING THE SCREW AND IMPLANTING A NEW ONE. THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Paresthesia

  MAUDE report 18887271 ↗
• InjuryAug 15, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, A HARDWARE REMOVAL CASE WAS HAPPENED. DURING THE REMOVAL A VIPER PRIME CFXFEN SCREW CONSTRUCT IT WAS CLEAR THAT THERE WAS A BROKEN SCREW. THE SURGEON WAS NOT SURE IF THIS HAPPENED BEFORE THE CASE, OR DURING. THE PATIENT WAS NOT ADVERSELY EFFECTED DURING THE CASE. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE PORTION OF THE SCREW SECONDARY TO THE FACT THAT IT WOULD BE BEEN DETRIMENTAL TO THE PATIENT. NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 6X45MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15223670 ↗
• InjuryJan 10, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE PATIENT HAD ONE LEVEL TLIF WITH RIGHT L5-S1 UNILATERAL PEDICLE SCREW INSERTION ON (B)(6)2021. THE PATIENT WAS FELL AND FRACTURED S1 PEDICLE SCREW. PATIENT SUFFERED FROM LEFT SIDED LEG PAIN. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) VIPER PRIME CFXFEN XTAB 6X45MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13213672 ↗
• InjurySep 10, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR 2 LEVEL MINI-OPEN SURGERY WITH VIPER PRIME AND TLIF L4-S1. DUE TO EXTREME OSTEOPOROTIC BONE THE SCREW INCLUDING HEAD OF THE SCREW WENT THROUGH THE PEDICLE AND EXITED ANTERIOR OF THE VERTEBRAL BODY, THIS HAPPENED ON THE RIGHT SIDE IN L4 AS WELL AS S1. ON THE RIGHT SIDE EVERYTHING WENT WELL, THE TLIF WAS PERFORMED AND THE ROD AND INNIES SEATED AND CLOSED. WHEN IT WAS OBSERVED THAT THE SCREWS IN L4 AND S1 EXITED ANTERIORLY THE SURGEON TURNED ON THE LATERAL SIDE, WHILE THE AORTA AND THE VENA CAVA, DAMAGE OBSERVED SO FAR. A SMALL HEMATOMA CLOSE TO THE VENA CAVA WAS REMOVED. IN THE SAME LATERAL POSITION, THE SCREWS SECURELY REMOVED FROM POSTERIOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 240 MINUTES DELAY. THERE WERE PATIENT CONSEQUENCES WITH INFECTION AND INFLAMMATION, ETC. CONCOMITANT DEVICE REPORTED: UNKNOWN INNIES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFXFEN XTAB 6X45MM THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: Hematoma; No Code Available

  MAUDE report 10517897 ↗
• InjurySep 10, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR 2 LEVEL MINI-OPEN SURGERY WITH VIPER PRIME AND TLIF L4-S1. DUE TO EXTREME OSTEOPOROTIC BONE THE SCREW INCLUDING HEAD OF THE SCREW WENT THROUGH THE PEDICLE AND EXITED ANTERIOR OF THE VERTEBRAL BODY, THIS HAPPENED ON THE RIGHT SIDE IN L4 AS WELL AS S1. ON THE RIGHT SIDE EVERYTHING WENT WELL, THE TLIF WAS PERFORMED AND THE ROD AND INNIES SEATED AND CLOSED. WHEN IT WAS OBSERVED THAT THE SCREWS IN L4 AND S1 EXITED ANTERIORLY THE SURGEON TURNED ON THE LATERAL SIDE, WHILE THE AORTA AND THE VENA CAVA, DAMAGE OBSERVED SO FAR. A SMALL HEMATOMA CLOSE TO THE VENA CAVA WAS REMOVED. IN THE SAME LATERAL POSITION, THE SCREWS SECURELY REMOVED FROM POSTERIOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 240 MINUTES DELAY. THERE WERE PATIENT CONSEQUENCES WITH INFECTION AND INFLAMMATION, ETC. CONCOMITANT DEVICE REPORTED: UNKNOWN INNIES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFXFEN XTAB 6X45MM. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: Hematoma; No Code Available

  MAUDE report 10517890 ↗
• MalfunctionFeb 14, 2019Disconnection; Disconnection

  SALES REP LEFT VOICEMAIL (B)(4) 2019 REGARDING PRODUCT COMPLAINT. NO DETAILS PROVIDED. AWAITING FURTHER INFORMATION. DETAILS PROVIDED BY SALES REP (B)(4) 2019: THE COLLET CAME OUT OF THE VIPER PRIME SCREW AND WAS NOT ALLOWING THE ROD TO SEAT IN THE HEAD OF THE SCREW. SURGEON REMOVED SCREW AND RETRIEVED COLLET. NO FRAGMENTS OR ASSOCIATED SCREW COMPONENTS WERE FOUND. NEW SCREW WAS PLACED AND ROD SEATED WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339188 ↗
• InjuryMar 15, 2018Torn Material; Torn Material

  VIPER PRIME CORTICAL FIX SCREW DISASSEMBLED AND PREVENTED ROD FROM REDUCING. THIS REQUIRED REMOVAL OF ROD AND 2 ADDITIONAL SCREWS TO CORRECT THE ISSUE. NEW SCREWS WERE USED. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:ADDITIONAL INCISION SIZE WAS NEEDED AND APPROXIMATELY 45 MIN WAS ADDED TO PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES. ADDITIONAL CLARIFICATION FROM SALES REP: THE INTERNAL MECHANISM OF THE POLY FEATURE WAS NO LONGER WHERE IT WAS SUPPOSED TO BE. THE OTHER SCREW HAD PART OF THE THREAD SHEAR OFF PREVENTING A SET SCREW FROM ENGAGING. THIS WAS NOTICED AFTER ROD REMOVAL AND ATTEMPTS TO REPLACE SET SCREW WERE UNSUCCESSFUL.

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

  MAUDE report 7341782 ↗