CHESAPEAKE® Stabilization System 3601-13814Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857081147), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionDec 15, 2023Difficult to Insert; Difficult to Insert

  A COMPANY REPRESENTATIVE REPORTED THAT, DURING IMPLANTATION, A 3.5 X 14 MM CHESAPEAKE SCREW WOULD NOT LOCK INTO A THREE-SCREW CHESAPEAKE TITANIUM INTERBODY SPACER. THE SURGEON REMOVED THE 3.5 X 14 MM SCREW AND ATTEMPTED TO PLACE A 3.85 X 14 MM CHESAPEAKE SCREW INSTEAD. THE SECOND SCREW WOULD NOT LOCK AND, UPON REMOVING THE SECOND SCREW, A PIECE OF METAL WAS OBSERVED AND REMOVED. THE SURGEON DETERMINED THAT THE INTERBODY SPACER WAS SECURE WITH THE TWO APPROPRIATELY LOCKED SCREWS AND DID NOT ATTEMPT TO PLACE THE THIRD SCREW A THIRD TIME. THIS REPORT CAPTURES THE FIRST OF TWO CHESAPEAKE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337353 ↗