MOUNTAINEER 188311301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034156767), received between Mar 7, 2019 and Mar 7, 2019 — classified as 1 malfunction.

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

• MalfunctionMar 7, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED WITH ROBERT REID RRS SYSTEM (P/N AND LOT NUMBER WERE UNKNOWN) ON UNKNOWN DATE. ON (B)(6) 2019, THE EXTENSION SURGERY WAS PERFORMED WITH UNKNOWN REASON. DURING THE SURGERY, THE REPORTED DEVICE WAS TRIED TO CONNECT TO ALREADY IMPLANTED ROBERT REID RRS SYSTEM (P/N AND LOT NUMBER WERE UNKNOWN) AFTER HAMMERING. HOWEVER, IT WAS DIFFICULT TO CONNECT EVEN THOUGH THE SURGEON TRIED FOR ABOUT 30 MIN SUCH AS UNTIGHTENING THE SCREW. THEN, WHEN THE SURGEON REMOVED THE REPORTED CONNECTOR, IT WAS REPORTED THAT THE CONNECTOR HAD DISASSEMBLED. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE DEVICE, AND EVENTUALLY THE CONNECTOR COULD CONNECT TO ROBERT REID RRS SYSTEM. THERE WAS LESS THAN 30-MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8399881 ↗