Cannulated Screw System + 04.354.342Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810040632594), received between Aug 28, 2024 and Aug 28, 2024 — 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TYBER MEDICAL BECAME AWARE OF AN ADVERSE EVENT AS PART OF A RETROSPECTIVE CLINICAL STUDY INTO OUR HEADED SCREW SYSTEM. PATIENT REPORTED TO CLINIC 4 WEEKS POST-OP WITH INFECTION AT THE SURGICAL SITES AND PRESCRIBED MEDICATION. PATIENT WAS RADIOGRAPHICALLY FUSED AT 3 MONTHS POST-OP. THE PATIENT RETURNED AT 4.5 MONTHS POST-OP WITH THE INFECTION PERSISTING. HARDWARE WAS REMOVED AT 4.5 MONTHS POST-OP. THE PATIENT FULLY HEALED FROM THE INFECTION AT THE 10 MONTH POINT. ADVERSE EVENT REPORTED FROM CLINIC: AT 4 WEEKS POST OPERATIVE THE PATIENT WAS PLACED ON CLINDAMYCIN 300MG TID FOR 10 DAYS DUE TO HISTORY OF DIABETES AND OPEN ULCERATIONS. THE EVENT WAS INTERMITTENT, MODERATE, SERIOUS, AND NOT LIFE THREATENING. THE ACTIONS TAKEN FOR THIS EVENT REQUIRED THERAPY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THIS EVENT WAS NOT RELATED TO THE TYBER MEDICAL TRAUMA SCREW SYSTEM. THE CLINDAMYCIN WAS DISCONTINUED, AND THE PATIENT WAS SENT TO WOUND CARE FOR ADDITIONAL FOLLOW-UP AND WOUND TREATMENT. THE PATIENT HAD A SECOND VISIT BECAUSE THEIR WOUNDS DID NOT HEAL WITH ASSISTANCE OF WOUND CARE. THE PATIENT WAS SUBSEQUENTLY BROUGHT BACK TO THE OR FOR REMOVAL OF HARDWARE, INCISION AND DRAINAGE, AND APPLICA

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 20085856 ↗