VIPER 186760145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034465463), received between Oct 31, 2018 and Jan 12, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON PERFORMED AN UNKNOWN SPINAL PROCEDURE. ON (B)(6) 2021, THE SAME SURGEON PERFORMED A PERCUTANEOUS REMOVAL PROCEDURE WHERE TWO SCREWS ON L3 EACH SIDE HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 6.0MM X 45MM . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13237475 ↗
• InjuryJan 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON PERFORMED AN UNKNOWN SPINAL PROCEDURE. ON (B)(6) 2021, THE SAME SURGEON PERFORMED A PERCUTANEOUS REMOVAL PROCEDURE WHERE TWO SCREWS ON L3 EACH SIDE HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 6.0MM X 45MM . THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13237471 ↗
• MalfunctionDec 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION APPLIED TO THE 3RD LEFT LUMBAR PEDICLE ON (B)(6) 2019. AFTER INSERTING A ROD, THE SURGEON PLACED THE SETSCREW (179702000) AND TRIED TO APPLY TORQUE. BUT THE TORQUE DID NOT BECOME EFFECTIVE, AND THE SETSCREW AND THE CORTICAL FIX SCREW (186760145) BROKE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS LESS THAN 30-MINUTE SURGICAL DELAY. THE SURGEON X-RAYED THE PATIENT POSTOPERATIVELY AND CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9413741 ↗
• InjuryJan 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PLIF SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE SURGEON COULD NOT CUT THE TAB PROPERLY THUS THE SURGEON COULD NOT ATTACH IT TO THE DRIVER TIP. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8268294 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA POSTERIOR SPINE FUSION TO FIX TH11-L2 BY USING HA BLOCK (MANUFACTURER WAS PENTAX, P/N AND LOT NUMBER WERE UNKNOWN), SCREWS TO TH11, 12, L1 AND L2, AND SET SCREWS. AFTER THE PRIMARY SURGERY ON UNKNOWN DATE, THE SURGEON RECOGNIZED THAT THE PATIENT SUFFERED THE INFECTION. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE THE RODS, SET SCREWS, AND THE SCREWS AT TH12 AND L1, AND THE IMPLANTED THE NEW SCREWS (P/N AND LOT NUMBER WERE UNKNOWN) TO TH10 AND L3, AND THEN FIX WITH NEW RODS (P/N AND LOT NUMBER WERE UNKNOWN) AT TH10.11.L2.3 USING NEW SET SCREWS (P/N AND LOT NUMBER WERE UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8025700 ↗