VIPER PRIME 186770335SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034530161), received between Jun 5, 2019 and Jan 10, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L5/S1) FOR LUMBAR CANAL STENOSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. SINCE THE PATIENT HAD NEUROLOGICAL SYMPTOMS CAUSED BY THE IMPLANTS AFTER SURGERY, AN REOPERATION WAS PERFORMED SUBSEQUENTLY. IN THE REOPERATION, 2 SCREWS IN QUESTION WERE REMOVED, NEW SCREWS WERE INSERTED WITH A CHANGE IN ENTRY POINT AND DIRECTION, AND RE-FIXATION WAS PERFORMED. AS THERE ARE NO SCREWDRIVERS THAT CAN APPLY TO VIPER PRIME SCREWS AFTER BREAKING OF THEIR TABS, NEW SCREWS WERE INSERTED AFTER REMOVING THE SCREWS IN QUESTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21123256 ↗
• InjuryJul 6, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A TLIF (L5/S1) WAS PERFORMED FOR SPINAL STENOSIS. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2023 DUE TO LOOSENING OF THE SCREWS AND NON-UNION BETWEEN L5/S1. IN THE REVISION SURGERY, THE CAGE WAS REMOVED AND REPLACED WITH A NON-SYNTHES PRODUCT. THE SCREWS WERE REMOVED AND REPLACED WITH SCREWS OF A LARGER SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 35MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17266241 ↗
• InjuryJul 6, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A TLIF (L5/S1) WAS PERFORMED FOR SPINAL STENOSIS. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2023 DUE TO LOOSENING OF THE SCREWS AND NON-UNION BETWEEN L5/S1. IN THE REVISION SURGERY, THE CAGE WAS REMOVED AND REPLACED WITH A NON-SYNTHES PRODUCT. THE SCREWS WERE REMOVED AND REPLACED WITH SCREWS OF A LARGER SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 35MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17266237 ↗
• InjuryJul 6, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A TLIF (L5/S1) WAS PERFORMED FOR SPINAL STENOSIS. A REVISION SURGERY WAS PERFORMED IN JUNE 2023 DUE TO LOOSENING OF THE SCREWS AND NON-UNION BETWEEN L5/S1. IN THE REVISION SURGERY, THE CAGE WAS REMOVED AND REPLACED WITH A NON-SYNTHES PRODUCT. THE SCREWS WERE REMOVED AND REPLACED WITH SCREWS OF A LARGER SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 35MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17266233 ↗
• InjuryJul 6, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A TLIF (L5/S1) WAS PERFORMED FOR SPINAL STENOSIS. A REVISION SURGERY WAS PERFORMED IN (B)(6) OF 2023, DUE TO LOOSENING OF THE SCREWS AND NON-UNION BETWEEN L5/S1. IN THE REVISION SURGERY, THE CAGE WAS REMOVED AND REPLACED WITH A NON-SYNTHES PRODUCT. THE SCREWS WERE REMOVED AND REPLACED WITH SCREWS OF A LARGER SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 35MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17266232 ↗
• InjuryJun 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER THE POSTERIOR SPINE FUSION SURGERY, THE SURGEON RECOGNIZED THAT THE SCREW OF THE VIPERPRIM SYSTEM WAS CUT OUT DUE TO THE LOOSE TENSIONING UNDER X-RAY. THERE WAS LESS THAN THIRTY (30) MINUTES SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8671822 ↗