VIPER 186770040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034129662), received between Oct 5, 2017 and Apr 26, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN JAPAN THAT A PATIENT UNDERWENT A REMOVAL PROCEDURE ON (B)(6) 2022. IT WAS OBSERVED THAT WHEN THE SURGEON PUT STRESS TO THE SCREWDRIVER DEVICE FOR REMOVING THE SCREW DEVICE FROM THE HARDENED BONE, THE TIP OF THE SCREWDRIVER DEVICE BROKE OFF. ACCORDING TO THE REPORT, THE CORE AREA OF THE REMOVED SCREW DEVICE WAS DEFORMED. THERE WAS NO FRAGMENT GENERATED. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE LESION. THE SURGEON CONFIRMED THAT THE EVENTS WERE TRIGGERED BY THE PATIENT¿S HARDENED BONE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) MIS CANNULATED X-TAB 7X40MM TI DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

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

  MAUDE report 14213070 ↗
• MalfunctionJan 27, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN XLIF (EXTREME LATERAL INTERBODY FUSION) AT L4/5. WHEN SURGEON REMOVING THE SCREWS AT S., THE SCREWHEAD CAME OFF. SURGEON LEFT THE SHAFT IN THE PATIENT. ALL FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED WITH 30 MINUTES DELAY. THE PATIENT IS NOT SCHEDULED TO UNDERGO ANOTHER PROCEDURE. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 7X40MM TI. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238477 ↗
• InjuryDec 3, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED VIA MIS-TLIF TO FIX L4/5 ON UNKNOWN DATE. THE EXTENSION SURGERY TO EXTEND TO L4-SAI WAS PERFORMED ON (B)(6) 2018, AND WAS PLANNED TO KEEP USING L4/5 SCREWS. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT THE L5 LEFT SCREW WAS BROKEN DURING THE EXTENSION SURGERY. THE SURGEON DECIDED TO KEEP THE BROKEN SCREW INTO THE PATIENT¿S L5 BECAUSE THE SURGEON JUDGED THAT THE BROKEN SCREW WAS HARD TO REMOVE. THE SURGERY WAS COMPLETED BY USING ANOTHER SCREW TO IMPLANT THE EXTENSION ROD. AFTER THE SURGERY, THE SURGEON CHECKED THE X-RAY (BEFORE SURGERY X-RAY) FOUND THAT THE L5 LEFT SCREW WAS ALREADY BROKEN BEFORE THE SURGERY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Spinal Column Injury

  MAUDE report 8126288 ↗
• InjuryOct 5, 2017Separation Failure; Separation Failure

  POST-OP FILMS THE DAY AFTER THE CASE, REVEALED THAT THE X-TABS ON THE LEFT SIDE OF THE CONSTRUCT DID NOT FULLY BREAK OFF THE SCREW. THEY BROKE OFF JUST ABOVE THE THREADS. THE PATIENT WAS TAKEN BACK INTO SURGERY THE NEXT DAY TO REMOVE THE REMAINDER OF THE X-TAB.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 6918359 ↗