VIPER 179706990Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034266589), received between Jul 17, 2018 and Nov 15, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2018Break; Break

  IT WAS REPORTED: BROKEN ROD AT L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018), LOOSE PEDICLE SCREW L5 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018), BROKEN PEDICLE SCREW S1 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018), BROKEN ILIAC SCREW RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018), LOOSE PEDICLE SCREW L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018), BROKEN EXPEDIUM POLYAXIAL SCREWDRIVER / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018, BROKEN POWER EXPEDIUM / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8073914 ↗
• MalfunctionJul 17, 2018Break; Device Damaged by Another Device

  IT WAS REPORTED THAT WHILE THE SURGEON WAS TORQUEING THE SET SCREW AT THE END OF THE CASE AT NORMAL 80 THEN WANTED TO TORQUE AT 100. WHEN DOING SO, THE SET SCREW STRIPPED OUT AND COMPROMISED THE INNER SCREW THREADS OF THE SCREW. PULLED THE SCREW OUT AND REPLACED IT. NO ADVERSE EVENT AND PROLONGED SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695385 ↗