TESSYS® TESBASICRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250337101239), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Recent adverse event reports

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

• InjuryDec 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A JOIMAX TESSYS INSTRUMENT SET WAS USED ON A PATIENT UNDERGOING ENDOSCOPIC SPINAL SURGERY ON T12-L1. THE SURGERY WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED. POSTOPERATIVELY, THE PATIENT PRESENTED TO THE HOSPITAL EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH AN INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 5 DAYS TO TREAT THE INFECTION. THE INFECTION WAS TREATED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED. FOLLOW-UP DISCUSSION WITH THE DISTRIBUTOR ALLEGED THAT THE INFECTION MAY HAVE BEEN CAUSED BY RUSTED JOIMAX INSTRUMENTS THAT WERE IMPROPERLY REPROCESSED BY THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 18319616 ↗