VIPER PRIME 286750070Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705034507705), received between Nov 15, 2017 and Sep 22, 2026 — classified as 2 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Calibration Problem; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857332 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT THE DEVICES HAD BROKEN TIPS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428141 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT THE DEVICES HAD BROKEN TIPS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428100 ↗
• MalfunctionMay 11, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE WAS BENT. IT WAS NOT POSSIBLE TO PLACE AT SET SCREW FOR PLACEMENT OR FINAL TIGHTENING ON THE TIP OF THE HANDLE. ANOTHER INSTRUMENT WAS USED. SURGERY WAS PERFORMED AS PLANNED. NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142676 ↗
• MalfunctionMay 7, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25116321 ↗
• MalfunctionMay 7, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25116320 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THE SET SCREW SCREWDRIVER IS NOT RETAINING THE SET SCREW CAUSING IT TO DROP INTO THE MIS SURGICAL SITE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057697 ↗
• MalfunctionMar 18, 2026Break; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626006 ↗
• MalfunctionMar 13, 2026Break; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589151 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MIS DEGENERATIVE CASE, DURING INSERTION OF THE VIPER PRIME SET SCREW THE SURGEON NOTICED THAT THE LOCKING CAP SCREWDRIVER DID NOT ENGAGE PROPERLY IN THE SET SCREW WHEN APPLYING FORCE. THE TIP OF BOTH SET SCREWDRIVERS ON THE SET WERE STRIPPED PREVENTING THE APPLICATION OF FINAL TORQUE WITH THIS INSTRUMENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE SCREWDRIVER FROM THE SET, SO THE CONSTRUCT WAS LOCKED WITH THE CORRECT TORQUE. THE TIP OF THIS SCREWDRIVER ALSO SHOWS SIGNS OF EARLY WEAR THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326684 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MIS DEGENERATIVE CASE, DURING INSERTION OF THE VIPER PRIME SET SCREW THE SURGEON NOTICED THAT THE LOCKING CAP SCREWDRIVER DID NOT ENGAGE PROPERLY IN THE SET SCREW WHEN APPLYING FORCE. THE TIP OF BOTH SET SCREWDRIVERS ON THE SET WERE STRIPPED PREVENTING THE APPLICATION OF FINAL TORQUE WITH THIS INSTRUMENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE SCREWDRIVER FROM THE SET, SO THE CONSTRUCT WAS LOCKED WITH THE CORRECT TORQUE. THE TIP OF THIS SCREWDRIVER ALSO SHOWS SIGNS OF EARLY WEAR THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326682 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION REPORTED: THERE IS AN OVERLAP IN LOTNUMBERS AS WE HAVE DELIVERED SEVERAL OF THE SAME SCREWDRIVER TO DIFFERENT SETS (LOAN AND CONSIGNMENT SETS), ALL COMPLAINTS RELATE TO THE SAME ITEM NUMBER. AS SOME ITEMS ARE RETURNED FROM LOANSETS, WE CANNOT DETERMINE WHERE THE DEFECT OCCURRED, ONLY WHEN IT WAS NOTICED. THE FAILURE COULD HAVE OCCURRED SEVERAL CYCLES BEFORE THE NOTIFICATION. ALSO IF IT IS PREMATURE WEAR, THE INSTRUMENT DETERIORATES DURING MULTIPLE CONSECUTIVE USAGES. DESCRIPTIONS ARE SIMILAR AS THE ITEM IS USED THE SAME WAY AND DEFECTS ARE NOTICED DURING THE SAME STAGE OF THE PROCEDURE: FINAL TIGHTENING WITH TORQUE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326493 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MIS DEGENERATIVE CASE, DURING INSERTION OF THE VIPER PRIME SET SCREW THE SURGEON NOTICED THAT THE LOCKING CAP SCREWDRIVER DID NOT ENGAGE PROPERLY IN THE SET SCREW WHEN APPLYING FORCE. THE TIP OF SET SCREWDRIVERS ON THE SET WERE STRIPPED PREVENTING THE APPLICATION OF FINAL TORQUE WITH THIS INSTRUMENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE SCREWDRIVER FROM THE SET, SO THE CONSTRUCT WAS LOCKED WITH THE CORRECT TORQUE. THE TIP OF THIS SCREWDRIVER ALSO SHOWS SIGNS OF EARLY WEAR. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326492 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A SPINAL POSTERIOR FIXATION PERFORMED ON (B)(6) 2026.WHEN USING THE INSERTER, THE NURSE PRESSED THE TIP OF THE SCREWDRIVER AGAINST THE SET SCREW LIS TO GRASP IT, AND THEN TRIED TO REMOVE IT, BUT IT BECAME UNABLE TO BE REMOVED.A DIFFERENT SET SCREW AND SCREWDRIVER WERE USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321903 ↗
• MalfunctionFeb 3, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING A MINIMALLY INVASIVE DEGENERATIVE PROCEDURE THAT THE VIPER PRIME SET SCRW INSERT EXPERIENCED A FAILURE INVOLVING THE TIP OF BOTH SET SCREWDRIVERS IN THE SET BECOMING STRIPPED, PREVENTING PROPER ENGAGEMENT WITH THE SET SCREW AND MAKING IT IMPOSSIBLE TO SET THE FINAL TORQUE WITH THESE INSTRUMENTS. THE ISSUE WAS IDENTIFIED INTRA-OPERATIVELY, AND THE SURGERY WAS COMPLETED USING AN ALTERNATIVE SCREWDRIVER, ENSURING THE CONSTRUCT WAS LOCKED WITH THE CORRECT TORQUE. THERE WAS NO DELAY IN THE PROCEDURE AND NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245980 ↗
• MalfunctionFeb 3, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING A MINIMALLY INVASIVE DEGENERATIVE PROCEDURE THAT THE VIPER PRIME SET SCRW INSERT EXPERIENCED A FAILURE INVOLVING THE TIP OF BOTH SET SCREWDRIVERS IN THE SET BECOMING STRIPPED, PREVENTING PROPER ENGAGEMENT WITH THE SET SCREW AND MAKING IT IMPOSSIBLE TO SET THE FINAL TORQUE WITH THESE INSTRUMENTS. THE ISSUE WAS IDENTIFIED INTRA-OPERATIVELY, AND THE SURGERY WAS COMPLETED USING AN ALTERNATIVE SCREWDRIVER, ENSURING THE CONSTRUCT WAS LOCKED WITH THE CORRECT TORQUE. THERE WAS NO DELAY IN THE PROCEDURE AND NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245946 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE EQUIPMENT WAS BROKEN. DURING A SPINE PROCEDURE. SURGERY WAS NOT DELAYED DUE TO THE EVENT AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389483 ↗
• MalfunctionAug 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  WHILE IN SURGERY THE SET SCREW INSERTED DID NOT ENTER IN THE SINGLE INNER SET SCREW. IT WAS DIFFICULT TO INSERT THE SINGLE INNER AND ALSO TO PERFORM THE FINAL TIGHTENING. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686809 ↗
• MalfunctionAug 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  WHILE IN SURGERY THE SET SCREW INSERTED DID NOT ENTER IN THE SINGLE INNER SET SCREW. IT WAS DIFFICULT TO INSERT THE SINGLE INNER AND ALSO TO PERFORM THE FINAL TIGHTENING. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. RUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686798 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SET SCREWDRIVER DOESN'T HOLD THE INNIES ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371952 ↗
• MalfunctionNov 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (T11-L3) FOR OVF ON (B)(6) 2024. WHEN THE FINAL TIGHTENING OF A SCREW WAS PERFORMED, THE TORQUE WRENCH WOULD NORMALLY IDLE THE HANDLE AFTER A CERTAIN TORQUE IS APPLIED, BUT THE HANDLE DID NOT GET IDLED, AND THE SCREWDRIVER BECAME DAMAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20762395 ↗
• MalfunctionSep 17, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT THE EVENT OCCURRED DURING INTRA-OP. THE PATIENT WAS INVOLVED, BUT NO REPORTED PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241271 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024, WHEN THE FINAL FASTENING OF THE SET SCREW, THE INSERTERS IN QUESTION WERE STRIPPED. THE FINAL FASTENING WENT WELL WITHOUT ANY PROBLEM WITH A DIFFERENT INSERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE VIPER PRIME SET SCREW INSERTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729023 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024, WHEN THE FINAL FASTENING OF THE SET SCREW, THE INSERTERS IN QUESTION WERE STRIPPED. THE FINAL FASTENING WENT WELL WITHOUT ANY PROBLEM WITH A DIFFERENT INSERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE VIPER PRIME SET SCREW INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728856 ↗
• MalfunctionJan 29, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVERS IN QUESTION WERE FOUND TO BE ROUNDED / STRIPPED. ANOTHER SET WAS OPENED, AND FINAL TIGHTENING WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN UNK SCREWDRIVER: VIPER PRIME. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595232 ↗