STERNALOCK® BLU SYSTEM 73-2623 (UDI 00841036141028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841036141028), received between Apr 3, 2019 and Jan 8, 2024 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Fracture; Fracture

  IT WAS FURTHER REPORTED THAT THE PLATE FRACTURED WHILE BENDING AND ANOTHER PLATE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463606 ↗
• MalfunctionMay 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Fluid Discharge

  MAUDE report 16945865 ↗
• MalfunctionMay 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Fluid Discharge

  MAUDE report 16945858 ↗
• InjuryNov 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10895815 ↗
• InjuryNov 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: No Information

  MAUDE report 10895718 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10644803 ↗
• InjuryApr 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: Wound Dehiscence

  MAUDE report 9910359 ↗
• 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 9696568 ↗
• 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 9591333 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED POST-OPERATIVE MEDIASTINAL HEMORRHAGE WITH TAMPONADE FOLLOWING THE IMPLANTATION OF STERNAL FIXATION PLATES. THE PATIENT HAD A REDO STERNOTOMY WITH RE-EXPLORATION OF MEDIASTINUM WITH EVACUATION OF CLOT AND WASHOUT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9591311 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED A WOUND INFECTION FOLLOWING STERNAL CLOSURE. IN (B)(6) 2019, THE PATIENT WAS CLOSED WITH THREE PLATES AFTER AN UNSPECIFIED CARDIAC EVENT. IN (B)(6) 2019, A SLIGHT SEPARATION AND AN INFECTION WAS NOTED IN THE WOUND WHICH WAS RESOLVED WITH ORAL MEDICATION KEFLEX. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9577873 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A STERNAL EMERGENT RE-ENTRY DUE TO AN UNKNOWN REASON. THE PATIENT WAS CLOSED WITH NEW PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9564297 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE RE-OPERATION WAS IN NO WAY RELATED TO A MALFUNCTION WITH THE STERNAL CLOSURE DEVICE. THEREFORE, THERE IS NO INDICATION OF A REPORTABLE EVENT AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9520469 ↗
• InjuryNov 27, 2019Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 9386762 ↗
• InjuryJul 18, 2019Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 8805764 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BYPASS SURGERY IN 2016. THE STERNLOCK PRODUCT WAS IMPLANTED IN (B)(6) 2017 AFTER A STERNAL WOUND HEALING DISORDER. AFTER APPROXIMATELY TWO YEARS, IMAGING SHOWED TRANSVERSE FRACTURES AND DEHISCENCE AT THE MANUBRIUM/XIPHOID. UPON REMOVAL OF THE PRODUCT, THREE SCREWS WERE FRACTURED AT THE LOWER THREADS. THE LOWER PART OF THE THREADS WERE NOT REMOVED FROM THE PATIENT'S BONE.

  Patient problems: Bone Fracture(s); Organ Dehiscence

  MAUDE report 8723549 ↗
• 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 8483769 ↗
• InjuryApr 3, 2019Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SEVERAL SCREWS LOOSENED FROM THE PLATES APPROXIMATELY FIVE TO SIX MONTHS POST-IMPLANTATION. THE PATIENT'S STERNUM WAS ORIGINALLY CLOSED WITH WIRE AFTER A BYPASS SURGERY. THE PATIENT EXPERIENCED A NON-UNION AND AS A RESULT, UNDERWENT A REVISION DURING WHICH HIS STERNUM WAS AGAIN CLOSED WITH WIRE. AFTER EXPERIENCING A SECOND NON-UNION, THE PATIENT UNDERWENT A SECOND REVISION DURING WHICH HIS STERNUM WAS CLOSED WITH STERNALOCK BLU. DURING A VISIT TO A CHIROPRACTOR, THE PATIENT WAS ADVISED THAT SEVERAL SCREWS WERE LOOSE AND ONE SCREW WAS JUST FLOATING AROUND. A CT SCAN WAS PERFORMED AND CONFIRMED THAT THE SCREWS WERE LOOSENED. A REVISION WAS PERFORMED DURING WHICH ONE PLATE AND EIGHT SCREWS WERE REMOVED FROM THE XIPHOID REGION OF THE PATIENT'S STERNUM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8481206 ↗
• InjuryApr 3, 2019Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING. DURING A VISIT TO A CHIROPRACTOR, THE PATIENT WAS ADVISED THAT SEVERAL SCREWS WERE LOOSE AND ONE SCREW WAS JUST FLOATING AROUND, CONFIRMED BY CT SCAN. DURING THE REVISION, THE LOWER PLATE AND SCREWS WERE REMOVED. THE PATIENT STATED THE TWO UPPER PLATES AND SCREWS WERE ALSO LOOSE, BUT REMAINED IMPLANTED BECAUSE THERE WOULD BE NOTHING HOLDING THE PATIENT TOGETHER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8481191 ↗