EXPEDIUM 179788740Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034081564), received between Feb 6, 2018 and Aug 6, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW HEADS GOT DISASSEMBLED FROM THE SCREW SHAFT ( 2 X 1797-88-740). THE SCREWS WERE IMPLANTED AS PER REGULAR PROCESS. HOWEVER, WHEN THE SURGEON CAME TO ADJUST THE SCREW WITH THE "HEAD TURNER" INSTRUMENT, THE HEADS OF THE SCREWS CAME LOOSE. THE SURGEON HAD TO REMOVE THE SCREWS USING THE STANDARD SCREWDRIVER AND REPLACED THEM WITH NEW SCREWS. REPLACEMENT SCREWS WILL BE NEEDED - NO CHARGE PO WILL BE SUBMITTED SHORTLY. PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE:REPLACED WITH NEW SCREWS. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7753056 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW HEADS GOT DISASSEMBLED FROM THE SCREW SHAFT ( 2 X 1797-88-740). THE SCREWS WERE IMPLANTED AS PER REGULAR PROCESS. HOWEVER, WHEN THE SURGEON CAME TO ADJUST THE SCREW WITH THE "HEAD TURNER" INSTRUMENT, THE HEADS OF THE SCREWS CAME LOOSE. THE SURGEON HAD TO REMOVE THE SCREWS USING THE STANDARD SCREWDRIVER AND REPLACED THEM WITH NEW SCREWS. REPLACEMENT SCREWS WILL BE NEEDED - NO CHARGE PO WILL BE SUBMITTED SHORTLY. PATIENT CONSEQUENCE? : NO. ACTION TAKEN FOR PROCEDURE:REPLACED WITH NEW SCREWS. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7753022 ↗
• MalfunctionFeb 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TWO COMPLAINTS FROM ONE PROCEDURE: WHILE IN SITU BENDING ROD, ROD BROKE BETWEEN BENDERS. ROD WOULD NOT SEAT PROPERLY WITHIN SCREW TULIP, ROD WAS REMOVED AND UPON INSPECTION, SCREW COLLET WAS IMPROPERLY LOCATED WITHIN THE TULIP. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:ADDITIONAL HOUR OF SURGERY TO REMOVE AND REPLACE ROD TWICE. ACTION TAKEN FOR PROCEDURE:1) BROKEN ROD REMOVED AND NEW ROD CONTOURED AND INSERTED ROD AND ALL SET SCREWS REMOVED, FAULTY SCREW REMOVED AND REPLACED, ROD AND ALL SET SCREWS RE-INSERTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7245314 ↗