NA 254505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705012978), received between Jan 22, 2019 and Jan 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJan 22, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SOCTOR HAD DIFFICULTY PLACING ABSOLUTE INTSCR 9X23MM *EA DEVICE. ACCORDING TO THE REPORTER, THE END SCREW THREAD WAS DIFFERENT FROM THE OTHERS. T WAS FURTHER REPORTED THAT THE THREAD WAS NOT UNIFORM ON BOTH SIDES. AT THE END OF THE SCREW, THE THREAD ON ONE SIDE WAS FLATTENED. IT WAS REPORTED THAT THE SCREW HAS NEVER BEEN USED. THE DOCTOR TRIED TO USE IT BUT WAS IMPOSSIBLE AND HAD TO USE ANOTHER SCREW TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF FIVE MINUTES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 8266620 ↗