STERNALOCK® BLU SYSTEM 73-2643 (UDI 00841036141042)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841036141042), received between Mar 20, 2019 and May 17, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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. How this data works · Data updated Oct 13, 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.

• 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 16945854 ↗
• 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 10644715 ↗
• 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 9520477 ↗
• InjurySep 5, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PLATE FRACTURED POST-OPERATIVELY FOLLOWING THE FIXATION OF THE STERNUM. ONE OF THE THREE IMPLANTED PLATES WAS FOUND TO BE FRACTURED. THE THREE PLATES WERE REMOVED IN A REVISION TWENTY-FIVE (25) DAYS AFTER IMPLANTATION AND THE STERNUM WAS FIXATED WITH ADDITIONAL PLATES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Injury; No Patient Involvement

  MAUDE report 8966957 ↗
• 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 STERNALOCK 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 8483776 ↗
• 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 8437586 ↗
• 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 8437582 ↗