VIPER 186727535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034282435), received between Mar 6, 2023 and Feb 6, 2024 — 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.

• MalfunctionFeb 6, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT A YOUNG PATIENT UNDERWENT A T12-L2 FIXATION IN (B)(6) 2022 FOLLOWING A BURST FRACTURE OF L1. SHORTLY BEFORE THE NORMAL ABLATION SURGERY, ABOUT A YEAR LATER, ONE FOUND THAT ONE SCREW TIP WAS BROKEN. THE SCREW ABLATION WAS PERFORMED ON (B)(6) 2024, BUT ONE SCREW TIP (FRAGMENT) WAS LEFT IN THE BODY OF T12 VERTEBRA. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650012 ↗
• InjuryMar 6, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED PATIENT WAS OPERATED IN (B)(6) 2023 .THIS CASE WAS A REMOVAL OF A T8-L2 POSTERIOR INSTRUMENTATION, NO SCREWS WERE REPLACED. A PEDICLE SCREW ON THE LEFT SIDE POSSIBLY T10 WAS BROKEN AND THE SURGEON REMOVED PART OF THE SCREW THAT HE COULD BUT A SEGMENT OF THE SCREW WAS LEFT INSITU. THIS PATIENT WAS PREVIOUSLY OPERATED ON (B)(6) 2015 FOR A T12 CORPECTOMY AND ANTERIOR CAGE FUSION T11-L1 : IMPLANTS FOUND ON SEARCH WHERE: 1 X 12MM CAGE 173400312, 1 X 24MM CAGE 173400324, 1 X 9MM CAGE 173401309 AND 1 X 60MM LOCKING SCREW 173450065. IT APPEARS THAT THERE IS ANTERIOR EXPEDIUM INSITU AS WELL BUT NO USAGE WAS FOUND AND THAT WOULD HAVE BEEN IMPLANTED ON THE SAME DAY 08.04.2015. A SECOND PROCEDURE WAS PERFORMED ON THE 18.04.2015 WHICH WAS T8-L2 POSTERIOR STABILISATION. IMPLANTS INCLUDED: 2 X (5X35) CFX SCREWS 186727535, 4 X (5X40) CFX SCREWS 186727540, 4 X (6X45) CFX SCREWS 186727645, 2 X 300MM VIPER STRAIGHT RODS186789300 AND 10 X VIPER SET SCREWS 179702000. IT WAS THIS CONSTRUCT THAT WAS REMOVED. ALL OF THESE IMPLANTS HAVE BEEN SENT TO CSSD AND WILL BE KEPT AT THE HOSPITAL FOR PICK UP. PATIENT CONSEQUENCE DES

  Patient problems: Failure of Implant

  MAUDE report 16485390 ↗