EXPEDIUM VERSE 199721735Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034442129), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryMar 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY. DURING REMOVAL STRIPS OF TITANIUM SHEARED FROM THE SCREW HEAD AND WERE SPREAD AROUND THE SURGICAL SITE. THE RISK TO THE PATIENT REQUIRED TIME TO BE TAKEN TO LOCATE ALL FRAGMENTS OF THE SCREW THREAD TO ENSURE NONE WAS LEFT IN THE WOUND. WHEN REMOVING A 5-LEVEL FIXATION L2-S1 DUE TO INFECTION THE CORRECTION KEYS STRIPPED THE SCREWS INTERNAL THREAD. THIS CAUSED SMALL STRIPS OF TITANIUM TO BE SPREAD AROUND THE SPINE. IMAGES OF DAMAGED IMPLANTS AND FRAGMENTS ATTACHED. A REQUEST HAS BEEN MADE FOR THE IMPLANTS TO BE STERILIZED FOR FURTHER INSPECTION. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 35 THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395603 ↗