NA 460.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587055046), received between Oct 3, 2018 and Oct 10, 2019 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE LARGE TITANIUM STERNAL LOCKING PLATE AND TITANIUM STERNAL LOCKING STAR PLATE BROKE INTO TWO PIECES DURING THE SURGEONS ATTEMPT TO BEND THE PLATES TO CONTOUR TO BONE. HE ATTEMPTED TO BEND ONE, THAT BROKE, THEN HE ATTEMPTED TO BEND THE SECOND. BROKEN DEVICES WERE EASILY REMOVED AS THEY WERE NOT IMPLANTED INTO THE PATIENT AT THAT TIME, SURGEON WAS BENDING THEM OFF THE SURGICAL SITE BY THE MAYO STAND. ANOTHER PLATE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS REPORTED WITH NO COMPLICATIONS. CONCOMITANT DEVICE REPORTED: UNKNOWN BENDING INSTRUMENTS: PLATE BENDER: TRAUMA (PART# /LOT# /QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) LARGE TI STERNAL LOCKING H-PLATE/8 HOLES. THIS IS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176732 ↗
• MalfunctionOct 3, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT STERNOTOMY. WHILE TIGHTENING A SELF-DRILLING SCREW INTO A STERNAL LOCKING H PLATE, THE HOLE OF THE PLATE WITH THE SCREW STILL INTACT GOT SEPARATED FROM THE REST OF THE PLATE. THE HOLE WITH THE SCREW STILL SITTING IN IT WAS REMOVED OFF THE FIELD AND SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT. THE REST OF THIS PLATE REMAINED FIXATED INTO THE STERNUM. THERE WAS NO REPORTED DELAY IN THE PROCEDURE. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL LOCKING H PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932389 ↗