VIPER 175710535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034034812), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionSep 12, 2018Break; Break

  DEPUY SYNTHES RECEIVED A VOICE MAIL FROM (B)(6) SALES REP, REPORTING THAT DURING A LAMINECTOMY PROCEDURE ON (B)(6) 2018 METAL PIECES OF DEVICE (B)(4) BROKE OFF IN THE PATIENT. HE STATED THAT THIS CAME FROM THE TEETH. THE SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT WAS NOT HARMED. THE SURGEON WAS UPSET THAT THIS OCCURRED. SYNTHES CREATED (B)(4) FOR THE DOCUMENTATION OF THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7869937 ↗