VIPER PRIME 186770345SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034530185), received between Apr 23, 2020 and Sep 10, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717467 ↗
• MalfunctionSep 10, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717457 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A MIS-TLIF (L4/5) FOR LUMBAR FORAMINAL STENOSIS ON (B)(6) 2025. FOR ONE INTERVERTEBRAL FUSION, AFTER ROD INSERTION AND FINAL TIGHTENING, THE SURGEON REMOVED THE TABS USING A TAB BREAKER. THE SURGEON POINTED OUT THAT THE TABS ON TWO OF THE FOUR SCREWS WERE UNUSUALLY HARD TO BREAK AND WERE MUCH HARDER THAN USUAL. THE SURGEON CONFIRMED THAT THE TAB BREAKER WAS INSERTED ALL THE WAY IN, AND TILTED IT OUTWARD WHEN BREAKING IT, BUT IT WAS SO HARD THAT IT ALMOST CAUSED THE PATIENT TO FLOAT, MAKING IT DIFFICULT TO BREAK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697776 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A MIS-TLIF(L4/5) FOR LUMBAR FORAMINAL STENOSIS ON (B)(6) 2025. FOR ONE INTERVERTEBRAL FUSION, AFTER ROD INSERTION AND FINAL TIGHTENING, THE SURGEON REMOVED THE TABS USING A TAB BREAKER. THE SURGEON POINTED OUT THAT THE TABS ON TWO OF THE FOUR SCREWS WERE UNUSUALLY HARD TO BREAK, AND WERE MUCH HARDER THAN USUAL. THE SURGEON CONFIRMED THAT THE TAB BREAKER WAS INSERTED ALL THE WAY IN, AND TILTED IT OUTWARD WHEN BREAKING IT, BUT IT WAS SO HARD THAT IT ALMOST CAUSED THE PATIENT TO FLOAT, MAKING IT DIFFICULT TO BREAK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697216 ↗
• MalfunctionAug 11, 2025Migration; Migration

  IT WAS REPORTED THAT THIS UNDERWENT A TLIF (L4/5) FOR SPINAL STENOSIS ON (B)(6) 2025, WITH A VIPER PRIME SCREW. AFTER SURGERY, A CT SCAN CONFIRMED THE VIPER PRIME SCREW (L5) HAD BECOME DISLODGED. THE SCREW WAS REPLACED ON (B)(6) 2025. SINCE THERE WAS NO SCREWDRIVER AVAILABLE TO ATTACH TO THE SCREW THAT HAD THE TAB CUT OFF, A NEW SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773441 ↗
• MalfunctionJun 19, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION (S1 LEFT) FOR SPINAL CANAL STENOSIS ON (B)(6) 2025. IN THE SURGERY, THE SURGEON REPLACED THE VIPER PRIME SCREW INSERTED IN S1 (LEFT) AND ALSO CHANGED THE INSERTION POINT TO THE LATERAL SIDE AND THE SCREW TRAJECTORY. AT THAT TIME, IT WAS POSSIBLE THAT THE TIP OF THE J-PROBE PIERCED THE ANTERIOR PART OF THE SACRUM. SINCE THERE WERE NO SCREWDRIVER AVAILABLE TO USE AFTER CUTTING THE TABS ON THE J-PROBE, A NEW SCREW WAS USED. AFTER THE SURGERY, THE SURGEON TOOK A CT SCAN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY.

  Patient problems: Bone Notching

  MAUDE report 22289786 ↗
• MalfunctionOct 3, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A POSTERIOR FUSION (L2) FOR DISH WHEN THE NURSE ATTEMPTED TO ATTACH THE SCREW IN QUESTION, SHE COULD NOT FIT THE SCREWDRIVER INTO THE SCREW CORE NO MATTER HOW MANY TIMES SHE TRIED. WHEN TESTED WITH A SCREW OF THE SAME SIZE, THE SCREWDRIVER AND ITS SCREW COULD BE ATTACHED AT ONE TIME. THEREFORE, IT WAS UNLIKELY THAT THE DRIVER WAS DEFECTIVE OR THAT THE NURSES LACKED SKILLS. AFTER THAT, THE DRIVER COULD BE ATTACHED TO THE OTHER SCREWS WITHOUT ANY PROBLEMS. HOWEVER, THE SCREW IN QUESTION COULD NOT BE ATTACHED NO MATTER HOW MANY TIMES IT WAS ATTEMPTED.

  Patient problems: Insufficient Information

  MAUDE report 20360125 ↗
• MalfunctionJul 11, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (L4, L5) FOR CERVICAL SPINAL CANAL STENOSIS ON (B)(6)2024. IN THE SURGERY, AFTER THE SCREWS WERE INSERTED AND THE RODS INSTALLED, THE FRONT AND SIDES OF THE IMAGE WERE CHECKED AND THE TABS WERE FOLDED FOR THE FINAL FASTENING. WHEN THE SURGEON DID A FINAL CHECK ON THE IMAGE BEFORE CLOSING, THE SCREWS IN QUESTION HAD TO BE REINSERTED. THE LEFT SET SCREW AND THE ROD IN QUESTION WERE REMOVED, AND THE L4 AND L5 SCREWS WERE EXTRACTED AND REINSERTED. VIPER PRIME USED A NEW SCREW BECAUSE THERE IS NO SCREWDRIVER THAT CAN INSERT A SCREW WITHOUT A TAB. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 45MM THIS IS REPORT 2 OF 3 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720153 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE SCREW IN QUESTION HAD BEEN ATTACHED TO A SCREWDRIVER AT FIRST, BUT IT WAS TO BE CHANGED TO ANOTHER SCREW DUE TO THE SURGEON¿S ORDER. THE SCREW COULD NOT BE DISCONNECTED FROM THE SCREWDRIVER EASILY, AND AFTER APPLYING CONSIDERABLE FORCE, THE SCREW WAS FINALLY DISCONNECTED FROM THE SCREWDRIVER. IN THE SURGERY, ANOTHER SCREW WAS USED TO AVOID THE SAME KIND OF EVENT OF EVENT OCCURRING IN THE PATIENT¿S BODY DURING TREATMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305169 ↗
• MalfunctionDec 16, 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 A POSTERIOR SPINAL FUSION PROCEDURE, BEFORE THE SURGERY, IT WAS CONFIRMED THAT TWO SCREWS AND TWO INSERTER SHAFTS COULD NOT BE DETACHED. TWO SCREWS WERE ATTACHED TO EACH OF THE TWO INSERTER SHAFTS FOR PREPARATION ACCORDING TO THE SURGICAL PLAN. SINCE THE STYLET WAS NOT PROPERLY ASSEMBLED, THE SURGEON TRIED TO REMOVE THE SCREWS ONCE. WHEN THE SURGEON TRIED TO LOOSEN THE GREEN KNOB OF INSERTER SHAFTS, IT WAS TOO HARD TO REMOVE THE SCREW. SAME FOR THE OTHER INSERT SHAFT AND SCREW. THE SURGERY WAS PERFORMED WITH OTHER COMPANY¿S IMPLANTS AND INSTRUMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SALES REP CONFIRMED THAT ONE OF THE TWO SCREWS AND INSERTER SHAFTS REPLICATED THE SAME NON-DETACHABLE SITUATION. THE OTHER WAS NOT REPRODUCIBLE. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018593 ↗
• MalfunctionDec 16, 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 A POSTERIOR SPINAL FUSION PROCEDURE, BEFORE THE SURGERY, IT WAS CONFIRMED THAT TWO SCREWS AND TWO INSERTER SHAFTS COULD NOT BE DETACHED. TWO SCREWS WERE ATTACHED TO EACH OF THE TWO INSERTER SHAFTS FOR PREPARATION ACCORDING TO THE SURGICAL PLAN. SINCE THE STYLET WAS NOT PROPERLY ASSEMBLED, THE SURGEON TRIED TO REMOVE THE SCREWS ONCE. WHEN THE SURGEON TRIED TO LOOSEN THE GREEN KNOB OF INSERTER SHAFTS, IT WAS TOO HARD TO REMOVE THE SCREW. SAME FOR THE OTHER INSERT SHAFT AND SCREW. THE SURGERY WAS PERFORMED WITH OTHER COMPANY¿S IMPLANTS AND INSTRUMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SALES REP CONFIRMED THAT ONE OF THE TWO SCREWS AND INSERTER SHAFTS REPLICATED THE SAME NON-DETACHABLE SITUATION. THE OTHER WAS NOT REPRODUCIBLE. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018583 ↗
• InjuryJun 28, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A REVISION PROCEDURE FOR TREATING LCS (LUMBAR CANAL STENOSIS). DURING THE PROCEDURE, WHEN SURGEON USED A SCREWHEAD ADJUSTER, THE SCREWHEAD OF THE VIPER PRIME CAME OFF. PREVIOUSLY, ON (B)(6) 2019 A PRIMARY PROCEDURE (PPS; PERCUTANEOUS PEDICLE SCREW FIXATION) WAS PERFORMED AT TH12-L4. THE REVISION PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Stenosis

  MAUDE report 12077007 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; 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 A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IN THE LUMBAR SPINE TREATING DEGENERATIVE DISEASE. DURING THE PROCEDURE, THE SURGEON WAS NOT ABLE TO APPLY TORQUE ON SCREWS (UNK) AND SETSCREWS (UNK) DURING FINAL FIXATION. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077036 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; 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 A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IN THE LUMBAR SPINE TREATING DEGENERATIVE DISEASE. DURING THE PROCEDURE, THE SURGEON WAS NOT ABLE TO APPLY TORQUE ON SCREWS (UNK) AND SETSCREWS (UNK) DURING FINAL FIXATION. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076995 ↗
• MalfunctionDec 25, 2020Device-Device Incompatibility; 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 A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IN THE LUMBAR SPINE TREATING DEGENERATIVE DISEASE. DURING THE PROCEDURE, THE SURGEON WAS NOT ABLE TO APPLY TORQUE ON SCREWS (UNK) AND SETSCREWS (UNK) DURING FINAL FIXATION. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X45MM TI THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11073614 ↗
• MalfunctionJul 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A PERCUTANEOUS PEDICLE SCREW FIXATION (PPS) SURGERY. DURING THE SURGERY, WHILE HE VIPER PRIME SCREW WAS BEING INSERTED HALFWAY THROUGH, IT BECAME LOOSE. THE SURGEON DETACHED THE SCREW AND TRIED TO HOLD IT WITH A SCREWDRIVER, BUT HE WAS NOT ABLE TO CONNECT THEM. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. PATIENT STATUS IS STABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN VIPER PRIME INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X45MM TI. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10219684 ↗
• MalfunctionApr 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR A SPINAL FUSION IN L5 TREATING PURULENT SPONDYLITIS ON (B)(6) 2020. THE SURGEON APPLIED VIPER PRIME SYSTEM AND TRIED TO INSERT A SCREW WITH XTAB (186770345S) . DUE TO THE PATIENT¿S ROBUST BONE, THE TIP OF THE STYLET BECAME DISTORTED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991853 ↗