VIPER 186760045Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 x 6.0 x 45mm · Class 2 · Implant

All models of VIPER (121)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034129204), received between Oct 5, 2017 and Feb 10, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Break1
Compatibility Problem1
Separation Failure1

Patient problems

Device Embedded In Tissue or Plaque1
Injury1
No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 10, 2023Compatibility Problem; Compatibility Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT IS NOT POSSIBLE TO PLACE INSERTION SLEEVE 286760350 OVER THE SCREW EXTENSIONS PRIOR TO INSERTION IN PATIENT. WHEN THE EXTENSIONS ON THE SCREWS ARE INSERTED APPROXIMATELY 1 CM THE SCREW GETS STUCK IN THE INSERTION SLEEVE. THIS HAS BEEN TESTED ON THE ACCOUNT MANAGERS OWN DEMO SLEEVE. SURGERY WAS PERFORMED AS PLANNED. NO CONSEQUENCE FOR PATIENT. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 6X45MM TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16352983 ↗
MalfunctionJan 14, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) CANNULATED EXTENDED TAB POLY SCREW WAS BROKEN OFF. THE PROCEDURE AND PATIENT INVOLVEMENT WERE UNKNOWN. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 6X45MM TI. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9586455 ↗
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 6918196 ↗

Device details

UDI-DI	`10705034129204`
Brand	VIPER
Model	186760045
Company	Medos International Sàrl
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 23, 2025

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.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease 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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