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VIPER 186760130Recalls & reported problems

Medos International Sàrl · VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 6.0mm x 30mm · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034465432), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 17, 2021Migration

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A POSTERIOR SPINAL FUSION TREATING THE TWELFTH THORACIC CENTRUM FRACTURE. DURING THE SURGERY, IT WAS NOTICED THAT AFTER THE SCREW FINALLY FIXATED, THE SCREW HAD CUT OUT INWARD. ALSO, IT WAS FOUND THAT THE SCREW AT L1 LEFT HAD BACKED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY LESS THAN 30-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 6X40MM TI. THIS IS REPORT 1 OF 2 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11340361 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.