VIPER 286760210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034214924), received between Aug 20, 2020 and Aug 20, 2020 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR THORACOLUMBAR FUSION IN TH11-L4 TREATING A RUPTURE FRACTURE, WHEN THE SURGEON TRIED TO BREAK OFF A NEW SCREW'S TABS WITH THE TAB BREAKER, POSSIBLY FRAGMENTED TAB(S) CAME OUT OF THE TAB BREAKER. THE FRAGMENTED TAB(S) WAS NOT THE ONE THE SURGEON TRIED TO BREAK OFF. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICES: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM EXT. TAB BREAKER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10432728 ↗
• MalfunctionAug 20, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR THORACOLUMBAR FUSION IN TH11-L4 TREATING A RUPTURE FRACTURE, WHEN THE SURGEON TRIED TO BREAK OFF A NEW SCREW'S TABS WITH THE TAB BREAKER, POSSIBLY FRAGMENTED TAB(S) CAME OUT OF THE TAB BREAKER. THE FRAGMENTED TAB(S) WAS NOT THE ONE THE SURGEON TRIED TO BREAK OFF. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICES: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM EXT. TAB BREAKER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431259 ↗