VIPER PRIME 286750083Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034507736), received between Mar 1, 2019 and Feb 12, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION STATES: 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 24326279 ↗
• 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 24326252 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMED A PLIF (L5/S1) FOR DEGENERATIVE DISEASE. DURING THE SURGERY, A TIP OF THE SCREWDRIVER BROKE AND WAS LEFT IN THE SET SCREW WHEN THE SURGEON ADDED COMPRESSION. THE SURGEON BROKE THE SET SCREW WITH A METAL CUTTER. THE ROD, SCREW, AND SET SCREW WERE REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372346 ↗
• MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE WORN AND STRIPPED. SURGERY WAS COMPLETED SUCCESSFULLY USING THE INSTRUMENTS, AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105955 ↗
• MalfunctionOct 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION (L5-S1) FOR LUMBAR DEGENERATIVE DISEASE ON (B)(6) 2024. VIPER PRIME WAS USED IN THE L5-S1PLIF CASE. IN THE SURGERY, THE SURGEON PERFORMED THE COMPRESSION PROCEDURE ACCORDING TO THE PROCEDURE MANUAL, AND THE TIP OF THE SCREWDRIVER BROKE OFF AND REMAINED IN THE SET SCREW. BECAUSE IT WAS DIFFICULT TO REMOVE THE TIP AND THE BREAKAGE OCCURRED AFTER SOME TORQUE HAD BEEN APPLIED, THE SURGEON CLOSED THE WOUND, LEAVING THE TIP OF THE SCREWDRIVER IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A VIPER PRIME COMP DRIVER, X25.

  Patient problems: Foreign Body In Patient

  MAUDE report 20351527 ↗
• MalfunctionJun 19, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A MIXED CONSTRUMENT WITH EXPEDIUM AND VIPER PRIME. UPON COMPRESSION, HE STRIPPED AND BROKE THE TIP OF THE COMPRESSOR "T" HANDLE INSTRUMENT. THE TIP WAS SUBSEQUENTLY RETRIEVED AND REMOVED. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE CASE WAS COMPLETED WITH OTHER INSTRUMENTS FROM EXPEDIUM AND VIPER PRIME. THE PATIENT WAS NOT IMPACTED, NO DELAY WAS OBTAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION TO ADD AT THIS TIME. THIS REPORT IS FOR ONE (1)VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569819 ↗
• MalfunctionMar 20, 2024Break; Break

  ALL THE SET SCREWS LOOKED SIMILAR AND IN GOOD CONDITION PRIOR IMPLANTATION. THE FRAGMENT REMAINED INSIDE THE PATIENT. NO OTHER OUTCOME REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18942308 ↗
• InjuryMar 28, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP OF THE DRIVER BROKE INSIDE THE SETSCREW DURING TIGHTENING. THE BROKEN TIP REMAINED LODGED INSIDE THE SETSCREW AND WAS NOT RETRIEVED. THE SURGEON WAS SATISFIED WITH TIGHTNESS OF THE SET SCREW AND NO FURTHER ACTION WAS NEEDED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VIPER PRIME COMPRESSOR DRIVER, X25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16631597 ↗
• MalfunctionJun 21, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE TIP OF A VIPER PRIME COMPRESSOR DRIVER BROKE OFF WHILE TIGHTENING A SCREW. THE PROCEDURE WAS FOR IMPLANTING A STRYKER CAGE, AND WAS COMPLETED SUCCESSFULLY AFTER REMOVING THE DRIVER FRAGMENT. THIS REPORT IS FOR A VIPER PRIME COMPRESSOR DRIVER, X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753173 ↗
• MalfunctionJan 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, DURING THE COMPRESSION AND TIGHTENING OF THE INNIE SCREW, THE TIP OF THE SCREWDRIVER (COMPRESSOR DRIVER X25) BROKE. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY. IT WAS NOT POSSIBLE TO PERFORM THE COMPRESSION OF THE VERTEBRAL SEGMENT, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE USUAL TORQUE SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172522 ↗
• MalfunctionDec 27, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE TIP OF DEVICE BROKE. THIS REPORT IS FOR A VIPER PRIME COMPRESSOR DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087960 ↗
• MalfunctionNov 30, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE DISTAL PORTION OF THE SCREWDRIVER FOR COMPRESSOR (X25) WAS BROKE. THE END OF THE SCREWDRIVER SHAFT WAS BREAK INSIDE THE SET SCREW. GENERATED FRAGMENTS ARE LEFT INTO THE PATIENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900969 ↗
• InjuryJul 22, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PLIF BETWEEN L3-L5 TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021, THE TIP OF THE DRIVER BROKE OFF WHILE A SETSCREW (UNK) WAS BEING TIGHTENED. THE SURGEON DECIDED TO LEAVE THE FRAGMENT IN THE PATIENTS BODY. PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES DELAY. THIS REPORT IS FOR A VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12212325 ↗
• MalfunctionJun 21, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) VIPER PRIME DRIVER AND TWO (2) VIPER PRIME SET SCREW INSERTERS WERE BROKEN DURING FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE TORQUE HANDLE AND SCREWDRIVER OF ANOTHER COMPATIBLE SET OF INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN DRIVER LEG (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SOLID COMPRESSOR LEG (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033403 ↗
• InjuryNov 3, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020, WHEN THE SURGEON USED THE COMPRESSOR DRIVER TO APPLY COMPRESSION TO THE SETSCREW, HE HAPPENED TO TIGHTEN THE SETSCREW EXCESSIVELY. THE TIP OF THE DRIVER BROKE OFF AND GOT STUCK IN THE SETSCREW. IT SEEMED IMPOSSIBLE TO REMOVE THE FRAGMENT AND PER SURGEON THE FRAGMENT WOULD NOT CAUSE FURTHER ADVERSE EVENT. SO, SURGEON LEFT THE FRAGMENT IN THE PATIENT¿S BODY AND COMPLETED THE REST OF THE PROCEDURE. CURRENTLY THE PATIENT IS HOSPITALIZED BUT RECOVERING. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: MIS SINGLE INNER SETSCW (PART # 186715000, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10779775 ↗
• MalfunctionJul 2, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, DURING THE INSERTION OF THE INNIES, DURING FINAL TIGHTENING THE SCREWDRIVERS WOULD NOT INSERT PROPERLY. IT WAS VERY DIFFICULT TO MAKE THE TORQUE LIMITING. DURING THE SAME PROCEDURE, THE COMPRESSION SCREWDRIVER WAS ALSO DAMAGED DURING THE COMPRESSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN (10) MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICES IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE VIPER PRIME COMP DRIVER WAS STRIPPED AND DEFORMED IN COUNTER CLOCKWISE DIRECTION. THIS DEVICE CONDITION WAS REASSESSED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2020. THIS REPORT IS FOR ONE (1) VIPER PRIME COMP DRIVER, X25. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10225481 ↗
• InjuryAug 13, 2019Break; Break

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION PROCEDURE TREATING SPINAL STENOSIS FOR THE LUMBAR SPINE ON (B)(6) 2019. WHILE THE SURGEON WAS USING THE VPRP COMPRESSOR DRIVER (286750083) WITH A COMPRESSOR DRIVER LEG AND A COMPRESSOR SOLID LEG, THE TIP OF THE COMPRESSOR DRIVER BROKE AND STUCK IN A SETSCREW¿S THREAD HOLE. THE SURGEON COMPLETED THE PROCEDURE WITHIN A 30-MINUTE DELAY, LEAVING THE FRAGMENT IN THE PATIENT¿S BODY. THE SURGEON COMMENTED THAT EXCESSIVE LOAD WAS PUT DURING THE COMPRESSION. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8887973 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT HEX 25 SCREWS AND SCREWDRIVER TIP WERE DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383853 ↗