STERNALOCK 360 SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 0
We found 3 models of STERNALOCK 360 SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2019 and Apr 8, 2026 — classified as 30 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported STERNALOCK 360 SYSTEM problems
Device problems
- Fracture31
- Adverse Event Without Identified Device or Use Problem11
- Migration4
- Detachment of Device or Device Component3
- Material Separation2
- Activation, Positioning or Separation Problem1
- Difficult to Insert1
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Information9
- No Known Impact Or Consequence To Patient9
- Failure of Implant4
- Hemorrhage/Blood Loss/Bleeding4
- No Code Available3
- No Consequences Or Impact To Patient3
- Wound Dehiscence2
STERNALOCK 360 SYSTEM models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STERNALOCK 360 SYSTEM 74-0004Plate, fixation, bone32 reports
- STERNALOCK 360 SYSTEM 74-0004Plate, fixation, bone18 reports
- STERNALOCK 360 SYSTEM 74-1193Plate, fixation, bone1 report
Recent STERNALOCK 360 SYSTEM adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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