STERNALOCK BLU SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 122
- Deaths reported
- 0
- Injuries reported
- 105
- Recalls
- 0
We found 31 models of STERNALOCK BLU SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 122 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2019 and Sep 2, 2026 — classified as 105 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (40 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 BLU SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem41
- Fracture40
- Loosening of Implant Not Related to Bone-Ingrowth14
- Migration13
- Migration or Expulsion of Device12
- Noise, Audible6
- Detachment of Device or Device Component2
- Material Deformation2
Patient problems
- Hemorrhage/Blood Loss/Bleeding20
- No Information20
- No Patient Involvement12
- Foreign Body In Patient11
- No Clinical Signs, Symptoms or Conditions7
- Pain7
- Unspecified Infection7
- Failure of Implant6
STERNALOCK BLU SYSTEM models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STERNALOCK® BLU SYSTEM 73-2623PLATE, FIXATION, BONE19 reports
- STERNALOCK® BLU SYSTEM 73-2414PLATE, FIXATION, BONE15 reports
- STERNALOCK® BLU SYSTEM 73-2416PLATE, FIXATION, BONE12 reports
- STERNALOCK® BLU SYSTEM 73-2418PLATE, FIXATION, BONE11 reports
- STERNALOCK® BLU SYSTEM 73-2412PLATE, FIXATION, BONE8 reports
- STERNALOCK® BLU SYSTEM 73-2643PLATE, FIXATION, BONE7 reports
- STERNALOCK® BLU SYSTEM 73-2645PLATE, FIXATION, BONE7 reports
- STERNALOCK® BLU SYSTEM 73-1952PLATE, FIXATION, BONE4 reports
- STERNALOCK® BLU SYSTEM 73-2622PLATE, FIXATION, BONE4 reports
- STERNALOCK® BLU SYSTEM 73-2643Plate, fixation, bone4 reports
- STERNALOCK® BLU SYSTEM 73-1191PLATE, FIXATION, BONE3 reports
- STERNALOCK® BLU SYSTEM 73-2412Plate, fixation, bone3 reports
- STERNALOCK® BLU SYSTEM 73-2418Plate, fixation, bone3 reports
- STERNALOCK® BLU SYSTEM 73-2410PLATE, FIXATION, BONE2 reports
- STERNALOCK® BLU SYSTEM 73-2716PLATE, FIXATION, BONE2 reports
- STERNALOCK® BLU SYSTEM 73-1952Plate, fixation, bone2 reports
- STERNALOCK® BLU SYSTEM 73-2414Plate, fixation, bone2 reports
- STERNALOCK® BLU SYSTEM 73-1194PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-5412PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-5414PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-2714PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-2420PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-1300Screw, Fixation, Bone1 report
- STERNALOCK® BLU SYSTEM SP-2890PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM SP-3215PLATE, FIXATION, BONE1 report
- STERNALOCK® BLU SYSTEM 73-2410Plate, fixation, bone1 report
- STERNALOCK® BLU SYSTEM 73-2416Plate, fixation, bone1 report
- STERNALOCK® BLU SYSTEM 73-2623Plate, fixation, bone1 report
- STERNALOCK® BLU SYSTEM 73-1191Plate, fixation, bone1 report
- STERNALOCK® BLU SYSTEM 73-1194Plate, fixation, bone1 report
- STERNALOCK® BLU SYSTEM SP-3037Plate, fixation, bone1 report
Recent STERNALOCK BLU SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50569111 ↗MalfunctionMay 19, 2026Fracture
IT WAS REPORTED THAT DURING STERNAL CLOSURE, WHILE INSERTING 18-MM SCREWS WITH A POWER DRIVER, THE HEAD OF ONE SCREW FRACTURED OFF, AND A SECOND SCREW COULD NOT BE INSERTED AS IT WOULD NOT PENETRATE THE BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25223324 ↗InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A LOOSENED SCREW/PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 22815003 ↗InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A LOOSENED SCREW/PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 22815002 ↗InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A LOOSENED SCREW/PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 22815000 ↗InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A LOOSENED SCREW/PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 22814997 ↗MalfunctionFeb 5, 2025Fracture; Fracture
NO FURTHER EVNET INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312502 ↗MalfunctionJan 8, 2024Fracture; Fracture
IT WAS FURTHER REPORTED THAT THE PLATE FRACTURED WHILE BENDING AND ANOTHER PLATE WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18463606 ↗MalfunctionAug 2, 2023Fracture; Fracture
IT WAS REPORTED THE DRILL BIT TIP FRACTURED OFF DURING SURGERY WITH NO IMPACT TO THE PATIENT. 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 17444743 ↗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 16945865 ↗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 16945858 ↗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 ↗InjurySep 8, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE THAT ONE SCREW FROM A 4-PACK WAS INSERTED WITH A CORDLESS SCREWDRIVER AS THE 31ST OF A TOTAL OF 32 SCREWS. THE SCREW FRACTURED OFF BEFORE IT COULD BE FULLY COUNTERSUNK INTO THE STERNUM. THE SCREW HEAD FRACTURED LEAVING THE THREADED PART IN THE PATIENT'S STERNUM. THE OTHER THREE (3) SCREWS OF THIS 4-PACK WERE PREVIOUSLY USED WITH THE PATIENT WITH NO ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15379271 ↗MalfunctionJul 22, 2022Fracture; Fracture
IT WAS REPORTED THAT A FRAGMENT OF THE TIP OF INSTRUMENT HAD BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. 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 15085497 ↗InjuryJul 1, 2021Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bacterial Infection
MAUDE report 12099370 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 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
- STERNALOCK 360 SYSTEM3 models · 51 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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