VIPER 186731835Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 8 x 35mm · 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 10705034352176), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Device-Device Incompatibility1

Patient problems

Failure of Implant1
No Code Available1

Recent adverse event reports

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

InjuryNov 5, 2020Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE IN THE LUMBAR SPINE TREATING TUBERCULOUS SPONDYLITIS. ON (B)(6) 2020 IT WAS REPORTED THAT THIS WAS A PPS (PERCUTANEOUS PEDICLE SCREW FIXATION) REVISION PROCEDURE AT L1-SAI REPLACING BROKEN-OFF RODS AND EXTENDING ROD RANGE. DURING THE REVISION AN IMPLANTED SCREW AT S1 RIGHT WAS REPLACED. IT WAS DIFFICULT TO RECONNECT THE RODS SO THE NEW SCREW WAS GOING TO BE REMOVED WITH A DRIVER SHAFT. THE DRIVER SHAFT¿S TIP BROKE OFF DUE TO THE PATIENT¿S ROBUST BONE QUALITY. THE FRAGMENT STUCK IN THE SCREW SO THE ROD WAS CUT IN THREE (3)CM LONG PIECES. THE THREE (3)CM PIECE WITH THE SCREW WAS ATTEMPTED TO BE REMOVED WHEN THE SCREW MOVED AND THE FRAGMENT WAS REMOVED. ANOTHER DRIVER SHAFT WAS USED TO REMOVE THE THREE (3)CM PIECE AND THE SCREW, BUT THE TIP OF THE DRIVER SHAFT BROKE OFF TOO. THE FRAGMENT WAS REMOVED AND THE SCREW REMAINED IN THE PATIENT¿S BODY. THE ROD WAS REPLACED AND IMAGING FOUND SOME FOREIGN OBJECTS (POSSIBLY FRAGMENTS) AT S1 LEFT (CLOSE TO THE PEDICLE). TWO PIECES WERE REMOVED, BUT THE POSTOPERATIVE X-RAY SHOWED ONE MORE FRAGMENT IN THE PATIENT¿S
Patient problems: Failure of Implant; No Code Available
MAUDE report 10793666 ↗

Device details

UDI-DI	`10705034352176`
Brand	VIPER
Model	186731835
Company	Medos International Sàrl
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	K110216
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, for degenerative disc disease devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page