VIPER PRIME 186770450SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034530260), received between Apr 9, 2020 and May 21, 2025 — classified as 4 injuries, 6 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION (L1-5) FOR BURST FRACTURE ON (B)(6) 2025. FOR THE CASE OF BURST FRACTURE FOR L3, PRIMEFS SCREWS WERE USED FOR L1-5 AND VBS FOR L3. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. X-RAYS SHOWED THAT THE RODS ON BOTH SIDES WERE FIRMLY FIXED WITHOUT PROTRUDING INTO THE L5 SCREW. HOWEVER, BECAUSE THE ROD WAS INSTALLED FROM THE CAUDAL SIDE, IT WAS DISCOVERED THAT THE THIN PART OF THE ROD TO GRASP THE ROD WAS FIXED TO THE L5 SCREW. IT WAS THOUGHT THAT THE SET SCREW WAS NOT CAPTURING THE ROD IN ONLY A LITTLE LESS THAN HALF OF THE L5 SCREW HEAD. SINCE THE TORQUE HAD BEEN APPLIED, THE SURGEON DECIDED TO FINISH THE SURGERY WITHOUT RE-INSTALLING THEM. DURING SURGERY, AFTER FASTENING THE ROD, THE SURGEON CONFIRMED USING AN IMAGE THAT THE ROD WAS PROPERLY PROTRUDING FROM THE CAUDAL (L5) SCREW. HOWEVER, IT WAS SPECULATED THAT THE SURGEON REMOVED THE ROD HOLDER BEFORE FINAL TIGHTENING AND THEN PERFORMED THE FINAL TIGHTENING, WHICH CAUSED THE ROD TO BECOME DISPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22064375 ↗
• MalfunctionMay 21, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION (L1-5) FOR BURST FRACTURE ON (B)(6) 2025. FOR THE CASE OF BURST FRACTURE FOR L3, PRIMEFS SCREWS WERE USED FOR L1-5 AND VBS FOR L3. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. X-RAYS SHOWED THAT THE RODS ON BOTH SIDES WERE FIRMLY FIXED WITHOUT PROTRUDING INTO THE L5 SCREW. HOWEVER, BECAUSE THE ROD WAS INSTALLED FROM THE CAUDAL SIDE, IT WAS DISCOVERED THAT THE THIN PART OF THE ROD TO GRASP THE ROD WAS FIXED TO THE L5 SCREW. IT WAS THOUGHT THAT THE SET SCREW WAS NOT CAPTURING THE ROD IN ONLY A LITTLE LESS THAN HALF OF THE L5 SCREW HEAD. SINCE THE TORQUE HAD BEEN APPLIED, THE SURGEON DECIDED TO FINISH THE SURGERY WITHOUT RE-INSTALLING THEM. DURING SURGERY, AFTER FASTENING THE ROD, THE SURGEON CONFIRMED USING AN IMAGE THAT THE ROD WAS PROPERLY PROTRUDING FROM THE CAUDAL (L5) SCREW. HOWEVER, IT WAS SPECULATED THAT THE SURGEON REMOVED THE ROD HOLDER BEFORE FINAL TIGHTENING AND THEN PERFORMED THE FINAL TIGHTENING, WHICH CAUSED THE ROD TO BECOME DISPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22064374 ↗
• MalfunctionSep 20, 2024Break; Entrapment of Device; Difficult to Advance; Break; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING AN OLIF (L3-5) FOR SPINAL CANAL STENOSIS, L3-5: ANTERIOR-POSTERIOR FIXATION, THE CONDUIT LATERAL WAS USED FOR THE ANTERIOR AND VIPER PRIME FOR THE POSTERIOR. IN THE SURGERY, WHEN INSERTING THE PPS INTO THE POSTERIOR L4 VERTEBRA, THE ANTERIOR PART OF THE L4 VERTEBRA WAS HARD AND THE VIPER PRIME SCREWS ON BOTH SIDES COULD NOT MOVE FORWARD FROM THE HARD AREA. WHEN TURNED A LITTLE HARDER, THE TIP OF LEFT VIPER PRIME SCREW APPEARED TO BE CHIPPED IN THE IMAGE. THEREFORE, THE VIPER PRIME SCREWS ON BOTH SIDES WERE REMOVED AND REPLACED WITH MINUS 5 MM SCREWS. IT WAS CONFIRMED THAT THE VIPER PRIME SCREW ON THE LEFT WAS MISSING ITS TIP (TIP TEETH). THERE WAS NO CHANGE IN THE PATIENT'S CONDITION DURING THE SURGERY. THE SURGEON COULD NOT CLEARLY SEE ON THE IMAGE WHETHER THE MISSING PART OF THE SCREW WAS WITHIN THE VERTEBRAE. THE SURGEON DETERMINED THAT THE MISSING PARTS MAY HAVE FALLEN INSIDE OR OUTSIDE THE BODY DURING THE REMOVAL PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20267071 ↗
• 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 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18467184 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: IMPLANT FAILURE COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466489 ↗
• InjuryOct 10, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  UPON EXAMINATION AFTER SURGERY, THE SURGEON COMMENTED THAT THIS EVENT HAD NO CAUSAL RELATIONSHIP TO THE CEMENT AND WAS NOT CAUSED BY THE SURGICAL TECHNIQUE. THE SURGEON ALSO COMMENTED THAT THIS EVENT APPEARS TO HAVE BEEN CAUSED BY BLOOD CLOT EMBOLISM IN THE LOWER LIMBS, AND THE PATIENT IS CURRENTLY IN STABLE CONDITION, HAVING BEEN PLACED ON AN ECMO AND TRYING TO REST.

  Patient problems: Pulmonary Embolism

  MAUDE report 17905391 ↗
• InjuryOct 10, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  UPON EXAMINATION AFTER SURGERY, THE SURGEON COMMENTED THAT THIS EVENT HAD NO CAUSAL RELATIONSHIP TO THE CEMENT AND WAS NOT CAUSED BY THE SURGICAL TECHNIQUE. THE SURGEON ALSO COMMENTED THAT THIS EVENT APPEARS TO HAVE BEEN CAUSED BY BLOOD CLOT EMBOLISM IN THE LOWER LIMBS, AND THE PATIENT IS CURRENTLY IN STABLE CONDITION, HAVING BEEN PLACED ON AN ECMO AND TRYING TO REST.

  Patient problems: Pulmonary Embolism

  MAUDE report 17905389 ↗
• MalfunctionMar 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION SURGERY ON (B)(6) 2023. AFTER INSERTION OF THE RIGHT L4 SCREW, THE TAB OF IT BROKE BECAUSE THE INSERTION ANGLE OF A SET SCREWDRIVER WAS MISALIGNED. AT THE SAME TIME, THREADS ON THE L4 RIGHT SCREW ALSO GOT DAMAGED, AND THE SURGEON HAD A STRANGE FEELING WHEN ENGAGING A ROD. A NEW SCREW WAS USED FOR THE PROCEDURE BECAUSE THE RIGHT L4 SCREW COULD NOT BE INSERTED PROPERLY. THE NEW SCREW AND ROD WERE ENGAGED SUCCESSFULLY. AFTER THE SURGERY, IT WAS FOUND THAT THE THREADS OF THE RIGHT L4 SCREW WERE DAMAGED, AND THERE WERE BURRS ON IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618261 ↗
• MalfunctionMar 2, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE VIPER PRIME SCREW COULD NOT BE CONNECTED TO THE SCREWDRIVER. IT SEEMS LIKE THE SCREWHEAD TORX WAS NOT ALRIGHT AND IT COULD NOT BE USED LIKE THAT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467621 ↗
• MalfunctionApr 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STYLET COULD NOT BE REMOVED FROM THE SCREW. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943660 ↗