VIPER 186770135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034465777), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER TO (B)(4), ON (B)(6) 2018, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO A LOWER BACK PAIN, THE BREAKAGE OF THE ROD (196789600) WAS FOUND UNDER THE X-RAY BETWEEN L4 AND L5 (RIGHT), AND BETWEEN L5 AND S (LEFT). ON (B)(6) 2018, THE RE-OPERATION WAS RESCHEDULED DUE TO THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL. ON (B)(6) 2018, THE RE-OPERATION WAS PERFORMED TO FIND THE CAUSE OF THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL, CONSIDERING THE SUSPECTED INFECTIONS. THE PROCEDURES WERE CONDUCTED IN THE FOLLOWING WAY. SCREWS AT L4, L5 AND S1 (RIGHT) WERE EXTRACTED AND NEW SCREWS WERE INSERTED AT L5 AND S1 TO CONNECT WITH UPPER RODS USING A CONNECTOR. A SCREW AT L5 (LEFT) WAS EXTRACTED TO CONNECT WITH UPPER RODS USING A CONNECTOR. SI SET SCREWS AT L4 AND OVER (BOTH SIDES) WERE REPLACED WITH NEW ONES, AND RODS AT FAR END WERE ALSO REPLACED WITH NEW ONES. ALSO, THE FOLLOWING WERE COMMENTED BY THE SURGEON. LOOSENING OF ALL THE SCREWS WERE OBSERVED WHEN EXTRACTED TORQUE WAS NOT PROPERLY APPLIED TO SI SET SCREWS WHEN EXTRACTED. BLACK-COLORED SUBSTANCES WERE SEEN AROUND THE SCREW AND THE ROD, WHICH MIGHT HAVE BEEN CAUSED BY THE METAL CORROSION. THE PATIENT¿S CRP LEVEL MIGHT HAVE

  Patient problems: Unspecified Infection

  MAUDE report 7736683 ↗