VIPER PRIME 286750200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034507811), received between Feb 18, 2020 and Feb 24, 2025 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT STYLETS BROKE DURING INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450670 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT STYLETS BROKE DURING INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450611 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT STYLETS BROKE DURING INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450609 ↗
• MalfunctionFeb 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING THE INSTALLATION OF ONE OF THE STYLETES, THE ARSENALERA EXPERIENCED RESISTANCE WHEN ATTEMPTING TO INSERT IT INTO THE VIPER PRIME SCREWDRIVER. WHEN REMOVING THE STYLET, THE PRESENCE OF ORGANIC MATTER WAS OBSERVED, WHICH LED TO CATALOGING BOTH THE AFFECTED STYLET AND ANY INSTRUMENTAL THAT WAS IN CONTACT WITH IT AS CONTAMINATED INSTRUMENTAL. BECAUSE OF THIS, BOTH STILETES WERE DISCARDED FROM SURGERY. THE PROBLEM WAS IDENTIFIED WITH THE PATIENT ALREADY UNDER ANESTHESIA, WHICH FORCED A CONSIDERABLE DELAY IN THE START OF THE SURGERY. GIVEN THIS SITUATION, IT WAS NECESSARY TO REPROCESS THE BOXES, WHICH CAUSED A SIGNIFICANT DELAY IN THE WARD AND EXTENDED THE EXPOSURE TIME OF THE PATIENT UNDER ANESTHESIA, EXCEEDING THE EXPECTED TIME. THIS DELAY NOT ONLY AFFECTED THE SAFETY AND WELL-BEING OF THE PATIENT, BUT ALSO GENERATED CONSIDERABLE DISTRUST AND DISCOMFORT WITHIN THE MEDICAL TEAM, WHO WERE FORCED TO MODIFY THE ORIGINAL SURGICAL PLAN IN ORDER TO CARRY OUT THE INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 21305532 ↗
• MalfunctionFeb 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING THE INSTALLATION OF ONE OF THE STYLETS, THE ARSENALERA EXPERIENCED RESISTANCE WHEN ATTEMPTING TO INSERT IT INTO THE VIPER PRIME SCREWDRIVER. WHEN REMOVING THE STYLET, THE PRESENCE OF ORGANIC MATTER WAS OBSERVED, WHICH LED TO CATALOGING BOTH THE AFFECTED STYLET AND ANY INSTRUMENTAL THAT WAS IN CONTACT WITH IT AS CONTAMINATED INSTRUMENTAL. BECAUSE OF THIS, BOTH STILETS WERE DISCARDED FROM SURGERY. THE PROBLEM WAS IDENTIFIED WITH THE PATIENT ALREADY UNDER ANESTHESIA, WHICH FORCED A CONSIDERABLE DELAY IN THE START OF THE SURGERY. GIVEN THIS SITUATION, IT WAS NECESSARY TO REPROCESS THE BOXES, WHICH CAUSED A SIGNIFICANT DELAY IN THE WARD AND EXTENDED THE EXPOSURE TIME OF THE PATIENT UNDER ANESTHESIA, EXCEEDING THE EXPECTED TIME. THIS DELAY NOT ONLY AFFECTED THE SAFETY AND WELL-BEING OF THE PATIENT, BUT ALSO GENERATED CONSIDERABLE DISTRUST AND DISCOMFORT WITHIN THE MEDICAL TEAM, WHO WERE FORCED TO MODIFY THE ORIGINAL SURGICAL PLAN IN ORDER TO CARRY OUT THE INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 21305379 ↗
• 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 STYLET. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Joint Laxity; Nerve Damage; Osteolysis

  MAUDE report 18452896 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) VIPER PRIME STYLET. THIS IS REPORT 4 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18449649 ↗
• MalfunctionDec 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PROCEDURE FOR STABILIZATION OF A FRACTURE AT L2 WAS PERFORMED WITH VIPER PRIME, USING TWO SCREWS IN L1 AND TWO SCREWS IN L3. AFTER THE COMPLETED SURGERY, IT WAS DISCOVERED THAT THE TIP OF THE STYLET HAD BROKEN OFF DURING SURGERY. RE-CHECKING THE X-RAY SHOWED THAT THIS PIECE WAS STILL WITHIN THE SCREW TIP AND CORTICAL BONE OF L1 ON THE RIGHT SIDE PEDICLE. THE SURGEON DECIDED NOT TO UNDERTAKE ANY ACTION AND LEAVE THE SCREW WITH THE TIP OF THE STYLET IN SITU. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE VIPER PRIME STYLET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400567 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS PLACING THE L5 PEDICLE SCREW ON THE PATIENT'S RIGHT USING THE VIPER PRIME SYSTEM. WHEN THE SURGEON CONFIRMED THE TIP OF THE SCREW/DRIVER ASSEMBLY WAS PROPERLY POSITIONED VIA INTRA-OPERATIVE FLUORO, HE ADVANCED THE PRIME STYLET APPROXIMATELY 3MM IN THE PEDICLE AND USED A MALLET TO ADVANCE THE EXTENDED STYLET UNTIL IT WAS FULLY SEATED. THE SURGEON FELT THAT WHEN HE DEPLOYED THE STYLET TO APPROXIMATELY 15MM, HE WAS UNABLE TO CONTINUE TO ADVANCE THE STYLET DUE TO HARD BONE. THE SURGEON CONFIRMED WITH INTRO-OPERATIVE FLUORO THAT THE STYLET WAS NOT ADVANCING, AND IT BECAME EVIDENT FROM THE IMAGE THAT THE STYLET WAS BENT AT THE DISTAL END OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE SCREW/DRIVER/STYLET ASSEMBLY FROM THE PEDICLE. ONCE REMOVED FROM THE INCISION, THE STAFF ATTEMPTED TO REMOVE THE BENT STYLET FROM THE SCREW DRIVER ASSEMBLY. WHILE THE STAFF CONTINUED TO ATTEMPT TO REMOVE THE BENT STYLET, THEY ASSEMBLED A NEW DRIVER/STYLET AND PROCEEDED TO LOAD A NEW 6.0X45MM PRIME SCREW. THE SURGEON INSERTED THE NEW SCREW WITH NEW DRIVER ASSEMBLY WITH NO FURTHER ISSUES. AFTER THE PROCEDURE WAS COMPLETED, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809389 ↗
• MalfunctionOct 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROCEDURE WHILE USING THE VIPER PRIME STYLET, THE SURGEON HAD TO ABANDON USING THE TRIALS BECAUSE OF THEIR INABILITY TO MAINTAIN A STRAIGHT LINE ON INSERTION WHICH MEANT THEY WOULD FLEX, AND OFTEN DEVIATE INTO THE SPINAL CANAL, WHICH MADE THEM UNSAFE TO USE. THE THREAD THAT CONNECTS THE SILVER HANDLE TO THE TIGHTENING DEVICE FOR THE CAGE WAS WORN, AND IS A WEAK POINT IN THE INSERTION DEVICE MECHANISM. THERE WAS A SURGICAL DELAY OF NINETY (90) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CAGE AND INSERTER. THIS REPORT IS FOR ONE (1) VIPER PRIME STYLET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715306 ↗
• MalfunctionAug 6, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A PPS (PERCUTANEOUS PEDICLE SCREW FIXATION) PROCEDURE. DURING THE PROCEDURE, WHEN OLIF WAS APPLIED IN L3-L4, TWO STYLETS BENT IN THE PATIENT BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THE PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME STYLET. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376068 ↗
• MalfunctionAug 6, 2020Material Twisted/Bent; Material Twisted/Bent

  CORRECTED INFORMATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT FOR A PERCUTANEOUS PEDICLE SCREW (PPS) FIXATION PROCEDURE ON (B)(6) 2020 AND NOT ON (B)(6), 2020 AS MENTIONED IN INITIAL REPORT. ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376067 ↗
• InjuryMay 21, 2020Break; Entrapment of Device; Material Twisted/Bent; Break; Entrapment of Device; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE SURGERY THE STYLET WAS BROKE ON PATIENT BONE. THE SURGEON WAS USED ALTERNATE INSTRUMENTS TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES. ALL GENERATED FRAGMENTS ARE STILL IN L3 LEFT PEDICLE. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10080305 ↗
• MalfunctionApr 22, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986086 ↗
• InjuryFeb 18, 2020Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCRUB NURSE HAD DIFFICULTY LOADING IMPLANT. SURGEON WAS ABOUT TO IMPLANT BUT NOTICED THE CAGE WAS NOT STRAIGHT. INTERFACE WITH INSERTER WAS NOT STRAIGHT AND IN ALIGNMENT WITH INSERTER. WE TRIED ANOTHER CONCORDE BULLET INSERTER, BUT THE CAGE WAS STILL NOT STRAIGHT. HAD TO OPEN ANOTHER IMPLANT WHICH LOADED CORRECTLY. THE SURGEON WAS GETTING S1 NERVE ROOT IRRITATION WITH NEUROMONITORING SO IMPLANTED AND REMOVED SECOND IMPLANT. HAD TO GET CT SCAN AND NAVIGATE REMAINING SCREWS. IT WAS REPORTED THAT THE IMPLANT WAS FAULTY. IMPLANT WAS DECONTAMINATED. THE VIPER PRIME SCREWDRIVER WAS NOT ABLE TO RELEASE SCREW AND STYLET WAS BENT AND HAD TO BE CUT. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT 10 MINUTES, NO FRAGMENTS WERE GENERATED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Nerve Damage; No Code Available

  MAUDE report 9724397 ↗