STERNALOCK 360 SYSTEM 74-0004 (UDI 00888233026604)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888233026604), received between Sep 14, 2020 and Apr 8, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THAT A STERNAL CLOSURE BAND SNAPPED DURING TIGHTENING. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820062 ↗
• MalfunctionMar 10, 2026Fracture

  IT WAS REPORTED THAT AN IMPLANT'S BAND FRACTURED WHEN TENSION WAS APPLIED DURING IMPLANTATION. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562103 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511441 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT A TITANIUM BAND WAS BROKEN DURING IMPLANTATION AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MIN. DELAY, NO PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300120 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT A STERNAL BAND WAS FRACTURED WHILE ATTEMPTING FINAL TENSIONING OF THE BAND. THE BROKEN BAND WAS REMOVED AND ANOTHER BAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903329 ↗
• InjuryFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT FOLLOWING A TEMPOROMANDIBULAR MANDIBULAR JOINT PROCEDURE, A BAND FRACTURE OCCURRED FOLLOWING A PATIENT COUGH. THE PATIENT WAS REVISED APPROXIMATELY ONE (1) WEEK LATER, AND THE SURGEON REMOVED AND REPLACED THE FRACTURED BAND, ALONG WITH THE SCREWS. NO CONTRIBUTING CONDITIONS OR ADDITIONAL PATIENT IMPACT WAS NOTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 21334359 ↗
• InjuryJan 14, 2025Fracture; Migration; Fracture; Migration

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

  Patient problems: Wound Dehiscence

  MAUDE report 21148343 ↗
• MalfunctionMar 28, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AN EIGHT HOLE PLATE WOULD NOT LOCK AND CUT THE BAND AFTER REPEATED ATTEMPTS. EVENTUALLY, THE BAND JUST SNAPPED PER THE SURGEON¿S EXPLANATION. THERE WAS NO HARM TO THE PATIENT. THE SURGICAL TEAM OPENED ANOTHER 360 KIT AND FINISHED THE STERNAL CLOSURE WITH IT. THE CASE WAS DELAYED LESS THAN 10 MINUTES WITH NO ADVERSE EFFECTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001300 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932117 ↗
• MalfunctionAug 21, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585147 ↗
• InjuryJul 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO A BROKEN STERNAL BAND, WHICH HAD BROKEN AT THE BOTTOM PORTION OF THE STERNUM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 17379659 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070228 ↗
• MalfunctionMar 29, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636476 ↗
• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANTATION, THE PRODUCT HAD A FRACTURED BAND. SUBSEQUENTLY, THE SURGEON USED A NEW DEVICE AND THE SURGERY WAS COMPLETED WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899705 ↗
• InjuryApr 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A STERNOTOMY PROCEDURE WHILE THAT TIGHTENING THE BANDS ON THE PLATES ONE OF THE BANDS SNAPPED. THE ISSUE DID NOT CAUSE ANY HARM TO THE PATIENT AND WAS NOTICED IMMEDIATELY. SURGEON REMOVED THE PLATE AND BAND THAT HAD BROKEN AND REPLACED IT WITH THE SAME TYPE OF ITEM. THE ISSUE CAUSED A DELAY OF 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134915 ↗
• MalfunctionOct 5, 2020Material Separation; Material Separation

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10631586 ↗
• MalfunctionOct 2, 2020Fracture; Fracture

  IT WAS REPORTED THE CABLE OF A STERNAL CLOSURE DEVICE FRACTURED WHILE REDUCING THE STERNAL HALVES. THE SURGEON WAS TRYING TO TIGHTEN THE DEVICE NEAR THE MANUBRIUM WHEN THE FRACTURE OCCURRED. THE DEVICE WAS REMOVED AND THE PATIENT WAS CLOSED WITH MULTIPLE WIRES. THE SURGEON FEELS THE LARGE ANATOMY OF THE PATIENT WAS RESPONSIBLE FOR THE DEVICE FAILURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10621478 ↗
• InjurySep 14, 2020Fracture; Fracture

  IT WAS REPORTED THE STERNAL CLOSURE PLATE FRACTURED POST-OPERATIVELY AND WAS REMOVED IN A REVISION SIXTEEN (16) DAYS FOLLOWING IMPLANTATION. THE BOTTOM PLATE APPEARED TO BE BROKEN WHEN THE PATIENT WAS OPENED. THAT PATIENT WAS NOT RE-PLATED AND WAS CLOSED WITH VACUUM-ASSISTED CLOSURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 10529679 ↗