STERNALOCK 360 SYSTEM 74-0004 (UDI 00841036190668)Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of STERNALOCK 360 SYSTEM (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet SternaLock 360 system is a metal plate-and-cable implant used to close the breastbone after open-heart surgery. The 32 reports mostly describe the plate or screws breaking, coming loose, or backing out of the bone, sometimes reopening the chest wound and requiring another operation; 24 reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00841036190668), received between Mar 6, 2019 and Nov 26, 2025 — classified as 24 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture14
- Adverse Event Without Identified Device or Use Problem11
- Detachment of Device or Device Component3
- Migration3
- Failure to Cut1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Separation1
Patient problems
- No Information8
- No Known Impact Or Consequence To Patient6
- Hemorrhage/Blood Loss/Bleeding4
- No Clinical Signs, Symptoms or Conditions3
- No Code Available3
- No Consequences Or Impact To Patient3
- Bacterial Infection1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656732 ↗InjuryApr 18, 2022Fracture; Fracture
IT IS REPORTED THAT THE PATIENT EXPERIENCED PAINT WAS REVISED DUE TO FRACTURED IMPLANTS.
Patient problems: Implant Pain
MAUDE report 14134909 ↗MalfunctionAug 2, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12258968 ↗InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bacterial Infection; Impaired Healing
MAUDE report 11368654 ↗MalfunctionSep 18, 2020Separation Failure; Failure to Cut; Separation Failure; Failure to Cut
IT WAS REPORTED THE CABLE OF THE STERNAL CLOSURE DEVICE WOULD NOT CUT AND THE PLATE WAS IMPLANTED WITHOUT THE CABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10553439 ↗MalfunctionSep 2, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10483914 ↗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 10391387 ↗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 10359300 ↗InjuryAug 3, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10356454 ↗InjuryAug 3, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Information
MAUDE report 10356444 ↗MalfunctionMay 14, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10055553 ↗InjuryApr 8, 2020Migration; Migration
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Information
MAUDE report 9934453 ↗InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Information
MAUDE report 9905653 ↗MalfunctionMar 31, 2020Fracture; Fracture
IT WAS REPORTED THAT A STERNAL BAND BROKE DURING IMPLANTATION. THE PATIENT WAS CLOSED WITH A COMBINATION OF WIRE CERCLAGE AND THE REMAINING PLATES WITH BANDS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9905485 ↗MalfunctionMar 12, 2020Fracture; Fracture
IT WAS REPORTED THAT WHILE TRYING TO CLOSE THE PATIENT'S CHEST USING STERNALOCK 360 THE BAND SNAPPED WHILE PERFORMING THE APPROXIMATION USING THE TENSIONER. SURGERY WAS DELAYED BY 10 MINUTES TO OPEN A NEW PACKAGE TO CLOSE THE CHEST. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9823187 ↗MalfunctionFeb 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A STERNAL CLOSURE IMPLANT DISASSEMBLED DURING IMPLANTATION. THE NEEDLE POPPED OFF THE BAND WHILE TRYING TO THREAD THE BAND UNDERNEATH THE STERNUM. THE PATIENT WAS CLOSED WITH A NEW STERNAL CLOSURE IMPLANT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9726910 ↗InjuryJan 27, 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 9635202 ↗InjuryJan 13, 2020Fracture; Fracture
IT WAS REPORTED A STERNAL BAND FRACTURED TWO MONTHS AFTER IMPLANTATION. PATIENT COMPLAINED OF PAIN NEAR THE XIPHOID AND X-RAY REVEALED THE BAND HAD SNAPPED ON THE IMPLANT. THE FRACTURED IMPLANT WAS REMOVED AND THE PATIENT WAS CLOSED WITH WIRE. PATIENT COUGHING MAY HAVE CONTRIBUTED TO THE FRACTURE OF THE IMPLANT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Pain
MAUDE report 9580413 ↗InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN EMERGENT RE-ENTRY DUE TO AN UNKNOWN REASON. STERNAL PLATES AND SCREWS WERE REMOVED AND THE PATIENT WAS CLOSED WITH NEW STERNAL PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Information
MAUDE report 9546956 ↗InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENT RE-ENTRY DUE TO BLEEDING. THE PATIENT WAS CLOSED WITH NEW STERNAL PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 9540045 ↗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 9513368 ↗InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE STERNAL CLOSURE IMPLANT WAS EXPLANTED DURING AN EMERGENT RE-ENTRY. THE IMPLANT WAS REPORTEDLY DIFFICULT TO REMOVE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Code Available
MAUDE report 9372166 ↗InjuryNov 25, 2019Adverse 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: No Code Available
MAUDE report 9372161 ↗MalfunctionNov 19, 2019Material Separation; Material Separation
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9342197 ↗InjuryOct 16, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 9198514 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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