VIPER PRIME 186760450SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034530109), received between Jun 30, 2021 and Feb 11, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THE PRODUCT HAD THE INCORRECT LABEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314119 ↗
• MalfunctionFeb 3, 2026Difficult to Advance; Compatibility Problem

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2026, AFTER INSERTING THE SCREW IN QUESTION, AN ALIGNMENT DEVICE WAS PLACED FOR CEMENT INJECTION. THE SURGEON COMMENTED THAT THE FIXATION FORCE WAS WEAKER THAN WITH OTHER SCREWS. THE OPEN CANNULA WAS ABLE TO BE INSERTED SAME AS THE OTHER SCREWS, BUT INSTEAD OF THE POLYLOCK THAT SHOULD HAVE BEEN APPLIED WHEN THE ALIGNMENT DEVICE WAS PLACED, THE HEAD OF THE SCREW IN QUESTION MOVED. THE SURGEON COMMENTED THAT HE HAD ALSO FELT DISCOMFORT WHEN INSERTING THE SCREW. AFTER REMOVING THE SCREW IN QUESTION AND REPLACING IT WITH A SCREW OF A LARGER DIAMETER, THE DISCOMFORT DURING SCREW INSERTION AND THE MOVEMENT OF THE HEAD AFTER THE ALIGNMENT DEVICE WAS PLACED DISAPPEARED. CEMENT WAS THEN INJECTED AS USUAL, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON COMMENTED THAT THE SCREW SOMETIMES DID NOT ADVANCE AND WOULD SPIN FREELY DURING INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248229 ↗
• MalfunctionSep 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW COULD NO LONGER BE RELEASED FROM THE VIPER PRIME SCREWDRIVER. THERE WAS NO SURGICAL DELAY AND NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X50MM S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182576 ↗
• MalfunctionAug 14, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY FOR L2 VERTEBRAL FRACTURE ON (B)(6) 2023. TH12, L1-L3, AND L4 WAS FIXED WITH PRIME FENESTRATED SCREWS. THE CEMENT WAS USED IN TH12 AND L4 ON BOTH SIDES. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, AFTER THE CONFIRMATION OF OSTEOSYNTHESIS. IN THE REMOVAL SURGERY, WHEN THE SCREW (L4) WAS REMOVED, BREAKAGE WAS CONFIRMED ON THE TIP. REMNANTS WERE OBSERVED WITHIN THE VERTEBRAE IN THE FRONT AND SIDE IN IMAGING. THE SURGEON DETERMINED THAT THERE WOULD BE NO IMPACT ON THE PATIENT BECAUSE IT WAS WITHIN THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON COMMENTED THAT IT WAS UNCLEAR WHETHER THE BREAKAGE WAS DUE TO METAL FATIGUE OR AN UNUSUAL FORCE APPLIED DURING THE EXTRACTION OPERATION, BUT IT IS EVIDENCE THAT THE BONE CEMENT IS WORKING THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A VIPER PRIME CFXFN XTB 6X50MM S. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19983305 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SECOND SURGERY PERFORMED 1 YEAR AFTER THE INITIAL SURGERY. THIS PC REPORTS THE CEMENT LEAKAGE AND DIFFICULTY IN THE FINAL FASTENING HAPPENED IN THE SECOND SURGERY. IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR INTERBODY FUSION (L3-4) PERFORMED WITH VIPER PRIME SCREWS ON AN UNKNOWN DATE ABOUT 1 YEAR AGO FROM (B)(6) 2024. AFTER THE SURGERY, ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO ADD XLIF TO L2-3 AND L4-5, AND TO REMOVE L3-4 SCREWS AND FIX L2-5. THE CAUSE OF THE SECOND SURGERY IS UNKNOWN. IN THE SURGERY, VIPER PRIME FENESTRATED SCREWS WERE INSERTED IN L2-5. THE CEMENT WAS INJECTED INTO L2, L4, AND L5 (NO CONCERNS ABOUT THE ANCHORAGE OF L3). THE INJECTION BEGAN ABOUT 11 MINUTES AFTER CEMENT MIXING. VISCOSITY WAS ADEQUATE. CEMENT WAS INJECTED IN THE ORDER OF L4, L5, AND L2. THE LATERAL XRAY DID NOT CLEARLY SHOW CEMENTATION AT THE TIME OF L4 INJECTION. AT THE SURGEON'S DISCRETION, 1.5 ML WAS INJECTED BILATERALLY. DURING L5 INJECTION, THE STATE OF THE CEMENT COULD BE SEEN THROUGH XRAY. ONE ML WAS INJECTED ON EACH SIDE. IN L2, CEMENT WAS INJECTED 0.4 ML ON THE LEFT SIDE AND 0.8 ML ON THE RIGHT SIDE AS SOME EFFICACY WAS FELT ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652377 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SECOND SURGERY PERFORMED 1 YEAR AFTER THE INITIAL SURGERY. THIS PC REPORTS THE CEMENT LEAKAGE AND DIFFICULTY IN THE FINAL FASTENING HAPPENED IN THE SECOND SURGERY. IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR INTERBODY FUSION (L3-4) PERFORMED WITH VIPER PRIME SCREWS ON AN UNKNOWN DATE ABOUT 1 YEAR AGO FROM (B)(6) 2024. AFTER THE SURGERY, ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO ADD XLIF TO L2-3 AND L4-5, AND TO REMOVE L3-4 SCREWS AND FIX L2-5. THE CAUSE OF THE SECOND SURGERY IS UNKNOWN. IN THE SURGERY, VIPER PRIME FENESTRATED SCREWS WERE INSERTED IN L2-5. THE CEMENT WAS INJECTED INTO L2, L4, AND L5 (NO CONCERNS ABOUT THE ANCHORAGE OF L3). THE INJECTION BEGAN ABOUT 11 MINUTES AFTER CEMENT MIXING. VISCOSITY WAS ADEQUATE. CEMENT WAS INJECTED IN THE ORDER OF L4, L5, AND L2. THE LATERAL XRAY DID NOT CLEARLY SHOW CEMENTATION AT THE TIME OF L4 INJECTION. AT THE SURGEON'S DISCRETION, 1.5 ML WAS INJECTED BILATERALLY. DURING L5 INJECTION, THE STATE OF THE CEMENT COULD BE SEEN THROUGH XRAY. ONE ML WAS INJECTED ON EACH SIDE. IN L2, CEMENT WAS INJECTED 0.4 ML ON THE LEFT SIDE AND 0.8 ML ON THE RIGHT SIDE AS SOME EFFICACY WAS FELT ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652376 ↗
• 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: 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: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE PDS (PEEK ROD) ,VIPER PRIME CFX FENESTRATED PRODUCTS. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18467159 ↗
• 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: ADJACENT SEGMENT PATHOLOGY, INSTABILITY, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 50MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Joint Laxity; Nerve Damage; Osteolysis

  MAUDE report 18453169 ↗
• InjuryOct 9, 2023Device Slipped; Device Slipped

  NO REMOVAL PROCEDURE WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 17897216 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS IN QUESTION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. AFTER THE SURGERY, ON AN UNKNOWN DATE, A FRACTURE OF THE VERTEBRAL BODY OCCURRED. ALTHOUGH THE PATIENT FEELS PAIN, THERE ARE NO PLANS FOR A REVISION SURGERY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16502693 ↗
• InjuryDec 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREW BREAKAGE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 16050174 ↗
• MalfunctionSep 7, 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 AN UNKNOWN PROCEDURE, THE VIPER PRIME SCREW COULD NOT BE LOOSENED FROM THE VIPER PRIME INSERTER SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER SCREW. THERE WAS A SURGICAL DELAY OF FOUR (4) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X50MM S. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434634 ↗
• InjuryJun 30, 2021Device Slipped; Device Slipped

  IT WAS FURTHER REPORTED THAT DURING HARDWARE REMOVAL PROCEDURE INSERTER WAS UNABLE TO CONNECT TO BACK OF CAGE (EVIDENCE OF STRIPPING). THIS INTRA-OP EVENT HAS BEEN REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Pain

  MAUDE report 12093933 ↗
• InjuryJun 30, 2021Device Slipped; Device Slipped

  IT WAS FURTHER REPORTED THAT DURING HARDWARE REMOVAL PROCEDURE INSERTER WAS UNABLE TO CONNECT TO BACK OF CAGE (EVIDENCE OF STRIPPING). THIS INTRA-OP EVENT HAS BEEN REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Pain

  MAUDE report 12093880 ↗