STERNALOCK® BLU SYSTEM 73-2416 (UDI 00841036141165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841036141165), received between Mar 20, 2019 and Aug 11, 2020 — classified as 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 10391405 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10359287 ↗
• 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 9910369 ↗
• 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 9513371 ↗
• InjuryNov 26, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375260 ↗
• InjurySep 5, 2019Fracture; Fracture

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

  Patient problems: Injury; No Patient Involvement

  MAUDE report 8968043 ↗
• InjuryJul 18, 2019Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 8805773 ↗
• 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 8555108 ↗
• 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 8483799 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION DUE TO A STERNAL COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 8482775 ↗
• InjuryMar 20, 2019Noise, Audible; Migration; Noise, Audible; Migration

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8437573 ↗
• InjuryMar 20, 2019Noise, Audible; Migration; Noise, Audible; Migration

  IT IS REPORTED THE PATIENT HAD A COUGH AND HEARD A STRANGE SOUND. THE SURGEON IDENTIFIED A SCREW HAD BACKED OUT. THE REVISION WAS PERFORMED DUE TO THE BONE(S) SEPARATED (HAD DEHISCENCE). REVISION WAS DONE AFTER OPMENTUM FILLING SURGERY. ZIMMER BIOMET STERNALOCK BLU SCREWS AND PLATES WERE PLACED DURING THE REVISION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8437572 ↗

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