VIPER 179704970Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034265827), received between Jan 17, 2019 and Jul 26, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE SCREWS COULD NOT BE REMOVED IN THE REMOVAL SURGERY. THE REMOVAL SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. ORIGINAL IMPLANT DATE IS UNKNOWN. THIS REPORT IS FOR ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 9 X 70MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17400438 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6), 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE SCREWS COULD NOT BE REMOVED IN THE REMOVAL SURGERY. THE REMOVAL SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. ORIGINAL IMPLANT DATE IS UNKNOWN. THIS REPORT IS FOR ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 9 X 70MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17400416 ↗
• MalfunctionJul 10, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A PELVIC RING FIXATION FOR PELVIC RING FRACTURE ON (B)(6), 2023. A FLEX CLIP ON REDUCTION DEVICE WAS USED TO SET A ROD, BUT TORQUE COULD NOT BE APPLIED TO THE SET SCREW FOR ANY LENGTH OF TIME AT THE FINAL TIGHTENING. WHEN THE SET SCREW WAS REMOVED ONCE AND CHECKED, IT WAS FOUND THAT ALL THE THREADS OF THE SET SCREW CRASHED. BOTH THE SAI SCREW AND THE SET SCREW WERE REPLACED BECAUSE THE THREADS OF THE SAI SCREW WERE ALSO DAMAGED. THE NEW SCREW INSERTED INSTEAD WAS THE SAME SIZE AND LENGTH AS THE DAMAGED SAI SCREW IN QUESTION. AGAIN, A FLEX CLIP ON REDUCTION DEVICE WAS USED THIS TIME TO SET A ROD. THE SURGEON DID THE FINAL TIGHTENING MANUALLY AT THE SURGEON¿S DISCRETION BECAUSE TORQUE COULD NOT BE APPLIED, SET A TRANSVERSE CONNECTOR, AND CLOSED THE WOUND. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 9 X 70MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295315 ↗
• MalfunctionMar 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POSTERIOR SPINAL FUSION (ILIUM) FOR THE SPINAL TRAUMA THE ROD WAS INSTALLED TO THE SCREW, AND THE FINAL LOCKING OF THE SET SCREW WAS PERFORMED. WHEN THE SURGEON TRIED TO REMOVE THE SET SCREW FOR ADJUSTMENT OF ROD POSITION, THE SURGEON FELT SPINNING IDLE, AND THE SET SCREW COULD NOT BE REMOVED FROM THE SCREW HEAD. ALTHOUGH THE SET SCREW WAS EVENTUALLY REMOVED, AND WAS FOUND BROKEN. ALL THE FRAGMENTS WERE REMOVED. IT WAS FOUND THAT THE SCREW HEAD THREADS WERE ALSO BROKEN, AND WERE REPLACED WITH A NEW SET OF SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 9 X 70MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495360 ↗
• InjuryJan 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2018, A SPINAL FUSION SURGERY (PRIMARY SURGERY) FOR SCOLIOSIS WAS PERFORMED WITH CANNULATED SAI POLYAXIAL SCREW IN QUESTION. THE SCREW WAS INSERTED IN S2 SPINE IN ACCORDANCE WITH SURGICAL TECHNIQUE IN THE PRIMARY SURGERY. ON (B)(6) 2018, THE SECONDARY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE SCREW FELL OUT FROM THE ROD. THE SURGEON REPLACED THE SCREW WITH ANOTHER POLYAXIAL SCREW (10 MM IN DIAMETER) IN THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 8258406 ↗