STERNALOCK® BLU SYSTEM 73-2418 (UDI 00841036147587)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841036147587), received between Apr 18, 2019 and Jul 1, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K110574, K121302, K161896); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2021Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection

  MAUDE report 12099370 ↗
• InjuryJul 1, 2021Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection

  MAUDE report 12099293 ↗
• InjuryJul 1, 2021Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection

  MAUDE report 12099267 ↗
• InjuryAug 11, 2020Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED A STERNAL DEHISCENCE SIX (6) DAYS FOLLOWING IMPLANTATION OF STERNAL CLOSURE DEVICES. A POST-OPERATIVE CT SCAN REVEALED THAT THE SCREWS HAD BACKED OUT OF THE MANUBRIUM AND BOTTOM PLATES WHILE THE CENTER X PLATE HAD BROKEN IN HALF. THE SURGEON ASSERTS THAT THE SCREW DEPTH WAS CORRECTLY MEASURED AND THE DEVICES WERE IMPLANTED CORRECTLY. THE SURGEON BELIEVES THAT THE PATIENT¿S COUGH CONTRIBUTED TO THE DEVICE FAILURE. THE STERNAL CLOSURE DEVICES WERE EXPLANTED SEVEN (7) DAYS FOLLOWING IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10391442 ↗
• InjuryJul 9, 2020Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 10253006 ↗
• InjuryApr 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TWO (2) WEEKS FOLLOWING IMPLANTATION OF STERNAL CLOSURE PLATES AND SCREWS DUE TO MECHANICAL STERNAL DEHISCENCE. THE IMPLANT FAILURE WAS DISCOVERED UPON FOLLOW-UP AFTER MITRAL VALVE REPLACEMENT. THE STERNAL CLOSURE IMPLANTS WERE REMOVED IN THE REVISION AND A REDO STERNAL CLOSURE WAS PERFORMED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Wound Dehiscence

  MAUDE report 9910378 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT INDICATED THE RE-OPERATION WAS PERFORMED DUE TO BLEEDING AND WAS NOT IN ANY WAY RELATED TO A DEVICE PROBLEM. THIS IS NOT A REPORTABLE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9513384 ↗
• InjuryNov 25, 2019Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

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

  Patient problems: Foreign Body In Patient

  MAUDE report 9372145 ↗
• InjuryJul 18, 2019Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 8805767 ↗
• InjuryApr 26, 2019Migration; Migration

  IT WAS REPORTED THE STERNALOCK 360 BAND CUT THROUGH THE STERNUM IN TWO PLACES DUE TO THE PATIENT HAVING A COUGHING FIT. THE SURGEON REMOVED THE STERNALOCK 360 AND REWIRED THE STERNUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8555120 ↗
• InjuryApr 18, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

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

  Patient problems: No Information

  MAUDE report 8529251 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110574, K121302, K161896. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2012 · Nov 23, 2011 · Terminated
  The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer cont