VIPER PRIME 186760240Recalls & reported problems
Medos International Sàrl · VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 x 40mm · Class 2 · Implant
All models of VIPER PRIME (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034509259), received between Nov 24, 2021 and Nov 30, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration4
- Device-Device Incompatibility1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON (B)(6) 2023. AN IMPLANT REMOVAL AND REVISION WAS SCHEDULED FOR (B)(6) 2023 BECAUSE THE L4 PEDICLE SCREWS FAILED WITH SUBSIDENCE INTO L4 WITH XPAC CAGE. THIS REPORT INVOLVES ONE VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 3 OF 6 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18241871 ↗InjuryNov 30, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON (B)(6) 2023. AN IMPLANT REMOVAL AND REVISION WAS SCHEDULED FOR (B)(6) 2023 BECAUSE THE L4 PEDICLE SCREWS FAILED WITH SUBSIDENCE INTO L4 WITH XPAC CAGE. THIS REPORT INVOLVES ONE VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 4 OF 6 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18238669 ↗InjuryNov 30, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON (B)(6) 2023. AN IMPLANT REMOVAL AND REVISION WAS SCHEDULED FOR (B)(6) 2023 BECAUSE THE L4 PEDICLE SCREWS FAILED WITH SUBSIDENCE INTO L4 WITH XPAC CAGE. THIS REPORT INVOLVES ONE VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 5 OF 6 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18238456 ↗InjuryNov 6, 2023Migration; Migration
THIS REPORT INVOLVES ONE VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18072399 ↗MalfunctionNov 24, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE PASSING THE VIPER PRIME 6X40 SCREW MOUNTED IN ITS RESPECTIVE SCREWDRIVER AND WITH THE STYLET, IT DID NOT EASILY ENTER THE PATIENT'S BONE AND THE SURGEON DECIDED TO REMOVE. IT WAS EVIDENT THAT THE STYLET WAS BENT AND JAMMED IN THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FEW MINUTES OF SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: MIS SINGLE INNER SETSCW (PART# 186715000, LOT# 299238, QUANTITY 4), MIS CANN POLY SCW 6X40MM,TI (PART# 186715640 , LOT# 149511, QUANTITY 3), MIS CANN POLY SCW 6X40MM,TI (PART# 186715640, LOT# TBVMF, QUANTITY 1) , VIPER2 LORDOTIC ROD-45MM (PART# 186788045, LOT# TBXZY, QUANTITY 1), CONF INTRO NDLE, DIA, 11G 6" (PART# 283903611, LOT# 271833, QUANTITY 2), VIPER PRIME STYLET (PART# 286750200S, LOT# 585424431, QUANTITY 1), VIPER PRIME STYLET (PART# 286750200S, LOT# SI5326111 , QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER PRIME X-TAB, 6X40MM TI. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12868422 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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