LCP 04.112.093Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982103048), received between Jul 9, 2020 and Jul 9, 2020 — classified as 1 malfunction.

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 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.

• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT ORTHOPEDIC PROCEDURE ON THE CLAVICLE. WHEN THE SURGEON WAS TRYING TO BEND PLATE IN AN OUT OF PLANE POSITION THE TITANIUM LOCKING COMPRESSION SUPERIOR CLAVICLE PLATE WITH LATERAL EXTENSION BROKE. ANOTHER PLATE WAS USED, FROM THE SET AND THE SURGERY COMPLETED WITH NO FURTHER ISSUES. THERE WERE FRAGMENTS GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) 3.5MM TI LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/7H/LT/120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251494 ↗