VIPER PRIME 286750031Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705034507583), received between Dec 20, 2019 and Feb 11, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (34 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(T12-L2) FOR COMPRESSION FRACTURE ON (B)(6) 2026. DURING THE SURGERY, THE SCREWDRIVER WAS SET WITH A SCREW OF A PREDETERMINED SIZE. HOWEVER, THE SIZE OF THE SCREW TO BE INSERTED INITIALLY WAS CHANGED, AND WHEN THE SURGEON WAS MADE TO REMOVE THE SCREW, THE SCREW IN THE SCREW FIXING PART BECAME HARD AND COULD NOT BE TURNED. THEREFORE, A DIFFERENT SCREWDRIVER SHAFT WAS USED AND THE SURGERY CONTINUED. HOWEVER, AFTER THE SCREW WAS PLACED IN THE SURGICAL FIELD, WHEN THE SURGEON TRIED TO REMOVE THE SCREW FROM THE SCREWDRIVER, IT BECAME HARD AND COULD NOT BE REMOVED. AS A SOLUTION, THE SCREW WAS TURNED USING PLIERS OR SIMILAR, AND THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316393 ↗
• MalfunctionFeb 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(T12-L2) FOR COMPRESSION FRACTURE ON (B)(6) 2026. DURING THE SURGERY, THE SCREWDRIVER WAS SET WITH A SCREW OF A PREDETERMINED SIZE. HOWEVER, THE SIZE OF THE SCREW TO BE INSERTED INITIALLY WAS CHANGED, AND WHEN THE SURGEON WAS MADE TO REMOVE THE SCREW, THE SCREW IN THE SCREW FIXING PART BECAME HARD AND COULD NOT BE TURNED. THEREFORE, A DIFFERENT SCREWDRIVER SHAFT WAS USED AND THE SURGERY CONTINUED. HOWEVER, AFTER THE SCREW WAS PLACED IN THE SURGICAL FIELD, WHEN THE SURGEON TRIED TO REMOVE THE SCREW FROM THE SCREWDRIVER, IT BECAME HARD AND COULD NOT BE REMOVED. AS A SOLUTION, THE SCREW WAS TURNED USING PLIERS OR SIMILAR, AND THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316315 ↗
• MalfunctionFeb 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(T12-L2) FOR COMPRESSION FRACTURE ON (B)(6) 2026. DURING THE SURGERY, THE SCREWDRIVER WAS SET WITH A SCREW OF A PREDETERMINED SIZE. HOWEVER, THE SIZE OF THE SCREW TO BE INSERTED INITIALLY WAS CHANGED, AND WHEN THE SURGEON WAS MADE TO REMOVE THE SCREW, THE SCREW IN THE SCREW FIXING PART BECAME HARD AND COULD NOT BE TURNED. THEREFORE, A DIFFERENT SCREWDRIVER SHAFT WAS USED AND THE SURGERY CONTINUED. HOWEVER, AFTER THE SCREW WAS PLACED IN THE SURGICAL FIELD, WHEN THE SURGEON TRIED TO REMOVE THE SCREW FROM THE SCREWDRIVER, IT BECAME HARD AND COULD NOT BE REMOVED. AS A SOLUTION, THE SCREW WAS TURNED USING PLIERS OR SIMILAR, AND THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316313 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PATIENT UNDERWENT A POSTERIOR FIXATION (T9-L3) FOR THORACIC VERTEBRAL FRACTURE ON (B)(6) 2026. WHEN INSERTING THE SCREW, THE SCREW WOULD NOT COME OFF THE SCREWDRIVER SHAFT, EVEN WITH PLIERS, SO THE SCREW WAS REMOVED. A NEW SCREW WAS INSERTED WITH A DIFFERENT SCREWDRIVER WITH A FEW MINUTE DELAY AND NO IMPACT TO THE PATIENT. OUTSIDE THE PATIENT, THE SCREW STILL DID NOT COME OFF THE SCREWDRIVER INITIALLY; EVENTUALLY IT WAS REMOVED AND NO DAMAGED WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220731 ↗
• 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 23389485 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY IT WAS MENTIONED THAT THE SCREWS CANNOT BE ATTACHED TO THE INSTRUMENT. THERE WAS NO PATIENT HARM. SCREW ON THE SCREWDRIVER COULD HARDLY BE MOVED, SO THE SCREW COULD NOT BE FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795959 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY IT WAS MENTIONED THAT THE SCREWS CANNOT BE ATTACHED TO THE INSTRUMENT. THERE WAS NO PATIENT HARM. SCREW ON THE SCREWDRIVER COULD HARDLY BE MOVED, SO THE SCREW COULD NOT BE FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795927 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY IT WAS MENTIONED THAT THE SCREWS CANNOT BE ATTACHED TO THE INSTRUMENT. THERE WAS NO PATIENT HARM. SCREW ON THE SCREWDRIVER COULD HARDLY BE MOVED, SO THE SCREW COULD NOT BE FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795891 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY IT WAS MENTIONED THAT THE SCREWS CANNOT BE ATTACHED TO THE INSTRUMENT. THERE WAS NO PATIENT HARM. SCREW ON THE SCREWDRIVER COULD HARDLY BE MOVED, SO THE SCREW COULD NOT BE FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795874 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A & P LUMBAR FUSION ON (B)(6) 2025. THERE WAS NO SCREWDRIVER FOR REMOVAL OF THE VIPER PRIME SCREW IN A REVISION SURGERY WHERE COUPLING WITH THE THREAD PART OF THE SCREW HEAD WAS NECESSARY. BECAUSE THE SCREWDRIVER DOES NOT ALLOW CONNECTION TO THE VIPER PRIME SCREW IMPLANT, A NEW VIPER PRIME SCREW WAS NECESSARY TO BE OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777782 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE SCREW SINCE IT'S CHARACTERISTICS WERE INTACT. THE REASON FOR REVISION WAS THAT THE SCREW WAS MISPLACED IN THE FIRST SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777628 ↗
• MalfunctionDec 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS POSTERIOR FUSION (L4) FOR A COMPRESSION FRACTURE ON (B)(6) 2024. A STRANGE METAL SOUND WAS HEARD WHEN THE SCREW WAS ATTACHED TO THE INSERTER SHAFT. THE SCREW WAS ATTEMPTED TO BE DETACHED FROM THE INSERTER TO BE CHECKED, BUT THE PART OF THE INSERTER SHAFT WHERE IT SHOULD BE LOOSE WHEN SCREWS ARE DETACHED DID NOT GET LOOSE. THE SCREW BECAME UNABLE TO BE DETACHED FROM THE INSERTER SHAFT. THE SCREW HAD BEEN MOUNTED AT AN ANGLE AND FORCED TO ATTACH TO THE INSERTER SHAFT. THIS EVENT OCCURRED BEFORE INSERTING THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864223 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A THORACOLUMBAR POSTERIOR FUSION FOR THORACIC SPINE TUMORS ON (B)(6) 2024. DURING SURGERY, THE SURGEON ATTACHED THE VIPER PRIME SCREW TO THE INSERTER SHAFT AND INSERTED THE SCREW. AFTER INSERTION, THE GREEN KNOB ON THE INSERTER SHAFT WAS TURNED BUT DID NOT ROTATE. ANOTHER PHYSICIAN WAS ABLE TO TURN IT BY FORCE AND REMOVE IT. AFTER THAT, ANOTHER SCREW WAS ATTACHED AND INSERTED, BUT IT STUCK AND COULD NOT BE REMOVED. AFTER POSTOPERATIVE CLEANING, WHEN THE SAMPLE IMPLANT WAS ATTACHED TO THE INSERTER SHAFT, IT COULD BE REMOVED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522559 ↗
• MalfunctionApr 18, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THIS WAS A REMOVAL SURGERY (THORACOLUMBAR VERTEBRAE) FOR TRAUMA ON (B)(6) 2024. BEFORE THE SURGERY, BLOOD STAINS WERE PRESENT ON THE INSERTER SHAFTS IN QUESTION. IT WAS WASHED AND STERILIZED. IT WAS NOT USED IN THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE VIPER PRIME INSERTER SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19139934 ↗
• MalfunctionApr 18, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THIS WAS A REMOVAL SURGERY (THORACOLUMBAR VERTEBRAE) FOR TRAUMA ON (B)(6) 2024. BEFORE THE SURGERY, BLOOD STAINS WERE PRESENT ON THE INSERTER SHAFTS IN QUESTION. IT WAS WASHED AND STERILIZED. IT WAS NOT USED IN THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE VIPER PRIME INSERTER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19139932 ↗
• MalfunctionMar 29, 2024Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE LOCKING SCREW ON THE INSERTER SHAFT COULD NO LONGER BE MOVED. THERE WAS NO PATIENT HARM. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT ONE SET SCREW OF THE DEVICE IS STUCK WITH COLLAR THREADS. SCREW ALSO HAS STRIPPED DAMAGE. THIS REPORT IS FOR A VIPER PRIME INSERTER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006402 ↗
• MalfunctionSep 19, 2023Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775607 ↗
• MalfunctionSep 19, 2023Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775605 ↗
• MalfunctionJul 28, 2023Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HCP WAS FOUND TO HAVE PROBLEMS WITH DETACHING THE SCREW FROM THE SCREWDRIVER. SOMETIMES THE SCREW IS HARD TO DETACH, AND SOMETIMES THE SCREW SITS A BIT LOOSE ON THE SCREWDRIVER TIP. THE SCREWDRIVERS SEEM WORN. THERE WAS NO REPORTED PATIENT IMPACT, NO REPORTED SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME INSERTER SHAFT. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415524 ↗
• MalfunctionJul 28, 2023Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HCP WAS FOUND TO HAVE PROBLEMS WITH DETACHING THE SCREW FROM THE SCREWDRIVER. SOMETIMES THE SCREW IS HARD TO DETACH, AND SOMETIMES THE SCREW SITS A BIT LOOSE ON THE SCREWDRIVER TIP. THE SCREWDRIVERS SEEM WORN. THERE WAS NO REPORTED PATIENT IMPACT, NO REPORTED SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME INSERTER SHAFT. THIS IS REPORT 6 OF 7 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415518 ↗
• MalfunctionJul 28, 2023Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HCP WAS FOUND TO HAVE PROBLEMS WITH DETACHING THE SCREW FROM THE SCREWDRIVER. SOMETIMES THE SCREW IS HARD TO DETACH, AND SOMETIMES THE SCREW SITS A BIT LOOSE ON THE SCREWDRIVER TIP. THE SCREWDRIVERS SEEM WORN. THERE WAS NO REPORTED PATIENT IMPACT, NO REPORTED SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME INSERTER SHAFT. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415516 ↗
• MalfunctionJul 28, 2023Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HCP WAS FOUND TO HAVE PROBLEMS WITH DETACHING THE SCREW FROM THE SCREWDRIVER. SOMETIMES THE SCREW IS HARD TO DETACH, AND SOMETIMES THE SCREW SITS A BIT LOOSE ON THE SCREWDRIVER TIP. THE SCREWDRIVERS SEEM WORN. THERE WAS NO REPORTED PATIENT IMPACT, NO REPORTED SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME INSERTER SHAFT. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415514 ↗
• MalfunctionMar 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, AFTER PLACING THE PEDICLE SCREW INTO THE VERTEBRAL BODY, THE SCREWDRIVER COULD NOT BE REMOVED FROM THE SCREW. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE EVENT. THE SCREW WAS REMOVED AND REPLACE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE BESIDES LONGER OR TIME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME INSERTER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501200 ↗
• MalfunctionDec 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CUSTOMER SERVICE TECHNICIAN HAD DIFFICULTY ASSEMBLING VIPER PRIME DRIVERS, THIS COMPLAINT INVOLVES FOUR DEVICES. THIS REPORT IS FOR ONE VIPER PRIME INSERTER SHAFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040337 ↗
• MalfunctionDec 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CUSTOMER SERVICE TECHNICIAN HAD DIFFICULTY ASSEMBLING VIPER PRIME DRIVERS, THIS COMPLAINT INVOLVES FOUR(4) DEVICES. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER SHAFT THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040328 ↗