STERNALOCK® BLU SYSTEM 73-1952 (UDI 00841036141004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036141004), received between Jun 21, 2019 and Jun 30, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10212711 ↗
• InjuryJan 10, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE STERNAL PLATE FRACTURED AND SCREWS BACKED OUT OF A PLATE SEVEN MONTHS POST-OPERATIVELY. IN (B)(6) 2019, THREE PLATES AND TEN SCREWS WERE IMPLANTED IN A RAVITCH PROCEDURE CORRECTING PECTUS EXCAVATUM. IN (B)(6) 2019, THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW PLATES AND SCREWS. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE REVISION SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9577846 ↗
• InjuryJan 10, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE STERNAL PLATE FRACTURED AND SCREWS BACKED OUT OF A PLATE SEVEN MONTHS POST-OPERATIVELY. IN (B)(6) 2019, THREE PLATES AND TEN SCREWS WERE IMPLANTED IN A RAVITCH PROCEDURE CORRECTING PECTUS EXCAVATUM. IN (B)(6) 2019, THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW PLATES AND SCREWS. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE REVISION SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9577737 ↗
• 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)

  MAUDE report 8723554 ↗