VIPER 279704055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034301242), received between Apr 17, 2024 and Sep 9, 2024 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR FUSION FOR DEGENERATIVE DISEASE ON (B)(6) 2024, DURING THE FINAL FASTENING OF THE SAI SCREW, IT WAS NOT POSSIBLE TO INSERT THE TORQUE DRIVER INTO THE SAI COUNTER TORQUE IN QUESTION. THE WELDED PART OF THE SAI COUNTER TORQUE IN QUESTION WAS PROTRUDING, SO THE SCREWDRIVER COULD NOT BE INSERTED. SINCE THE FINAL FASTENING WAS DONE BY GRIPPING THE ROD WITH A ROD HOLDER AND APPLYING TORQUE, THERE WERE NO PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169697 ↗
• MalfunctionApr 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A TRANSVERSE ILIAC ROD FIXATION (PELVIS) SURGERY ON (B)(6) 2024, DURING FINAL FASTENING OF THE SAI SCREW, ONLY ONE-THIRD OF THE TORQUE SHAFT WAS INSERTED INTO THE SAI COUNTER TORQUE IN QUESTION. FINAL FASTENING WAS DONE BY GRIPPING THE ROD WITH A ROD HOLDER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. UPON CHECKING THE INSTRUMENT AFTER SURGERY, IT WAS CONFIRMED THAT THE WELDS INSIDE THE TUBE HAD NOT BEEN GROUND AND THE SHAFT COULD NOT BE INSERTED. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123905 ↗