STERNALOCK® BLU SYSTEM 73-2645Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841036141059), received between Mar 11, 2019 and Feb 11, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A RE-OPERATION DUE TO HEMORRHAGE. THE PATIENT HAD SIGNIFICANT COAGULOPATHY AND BLEEDING FROM CHEST TUBES. CT SCANS DEMONSTRATED MODERATE MEDIASTINAL HEMATOMA. THE PATIENT HAD A RE-OPERATION FOR EXPLORATION AND WAS CLOSED WITH NEW STERNAL CLOSURE DEVICES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9696563 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED CHEST PAIN FOLLOWING THE IMPLANTATION OF STERNAL FIXATION PLATES. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Chest Pain

  MAUDE report 9591324 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER ASSESSMENT OF THE EVENT DETERMINED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND THERE IS NO ALLEGED MALFUNCTION. THEREFORE, THERE IS NO INDICATION OF A REPORTABLE EVENT AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 9577872 ↗
• InjurySep 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8968051 ↗
• InjuryAug 23, 2019Fracture; Fracture

  IT WAS REPORTED A STERNAL PLATE FRACTURED POST-OPERATIVELY. THE FRACTURED PLATE WAS DISCOVERED BY X-RAY THE FOLLOWING DAY AFTER SURGERY. THE SURGEON DOES NOT WISH TO RETRIEVE THE FRACTURED IMPLANT AND NO REVISION IS PLANNED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8926113 ↗
• InjuryApr 4, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO THE SCREWS PULLING OUT OF THE BONE RESULTING IN STERNAL SEPARATION. THE PATIENT'S STERNUM WAS ORIGINALLY CLOSED WITH WIRE AFTER A CARDIAC SURGERY APPROXIMATELY TWO MONTHS PRIOR TO IMPLANTATION OF STERNALOCK. THE WIRES FAILED AND STERNALOCK WAS IMPLANTED AS A RESULT. THE PATIENT REPORTED THAT HE FELT PAIN AND INSTABILITY WHILE AT A GUN RANGE AND IT WAS DETERMINED VIA X-RAY THAT THE SCREWS HAD PULLED AWAY FROM THE STERNUM ON ONE SIDE. SUBSEQUENTLY, ALL STERNLOCK PLATES AND SCREWS WERE REMOVED. THE SURGEON ADVISED THAT HE DOES NOT BELIEVE THAT THIS ISSUE WAS RELATED TO THE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8483813 ↗
• InjuryMar 11, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407645 ↗