VIPER 186727040Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 10 x 40mm · Class 2 · Implant

All models of VIPER (121)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034282336), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Not Applicable1
Spinal Column Injury1

Recent adverse event reports

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

InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION, L5 SCREW (LEFT) REMOVAL AND PEDICLE SUBTRACTION DR (B)(6), (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2015 DR (B)(6), (B)(6) PRIVATE. FIRST REVISION (B)(6) 2016 CF 5098185/(B)(4). SECOND REVISION (B)(6) 2016 CF 5098188/(B)(4). THIRD REVISION (B)(6) 2016 CF 5098030/(B)(4). FOURTH REVISION (B)(6) 2018 REVISION FOR BROKEN RODS - DR (B)(6), (B)(6) PRIVATE PATIENT RE-OPERATED ON TO REPLACE BILATERAL BROKEN RODS AND LOOSENING OF 3 SCREWS IN LOWER SECTION OF CONSTRUCT L4- PELVIS, BELOW INLINE CONNECTORS. ALL SET SCREWS,ROD CONNECTORS,THREE LARGER DIAMETER SCREWS AND TWO RODS REPLACED REPLACE BELOW CONNECTION POINT OF UPPER CONSTRUCT. FIFTH REVISION (B)(6) 2018 DR (B)(6), (B)(6) PRIVATE. PATIENT COMPLAINING OF L5 LEFT SIDED FORAMINAL PAIN AFTER REVISION SURGERY (B)(6) 2018. PATIENT RETURNED TO THEATRE AND HAD : SFX CROSSCONNECTOR, SET SCREWS, ROD TO ROD CONNECTORS AND RODS REMOVED FROM LEFT SIDE. LEFT L5 10 MM CFX SCREW WAS THEN REMOVED (DISCARDED)AND PEDICLE OSTEOTOMY PERFORMED. SFX CROSSCONNECTOR, SET SCREWS, ROD TO ROD CONNECTORS, RODS WERE REPLACED AND FINAL TIGHTENED. (B)(6).
Patient problems: Not Applicable; Spinal Column Injury
MAUDE report 7382198 ↗

Device details

UDI-DI	`10705034282336`
Brand	VIPER
Model	186727040
Company	Medos International Sàrl
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
Class	Class 2
FDA submission	K160879
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All ORTHOSIS, SPINAL PEDICLE FIXATION devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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