PECTUS SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 35 models of PECTUS SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2019 and Mar 23, 2026 — classified as 41 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Migration” (12 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 PECTUS SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem21
- Migration12
- Inadequacy of Device Shape and/or Size10
- Patient-Device Incompatibility6
- Malposition of Device2
- Patient Device Interaction Problem2
- Positioning Failure2
- Positioning Problem2
Patient problems
- No Known Impact Or Consequence To Patient14
- Pneumothorax9
- Failure of Implant8
- No Information6
- Pain5
- Edema4
- Burning Sensation3
- Hypersensitivity/Allergic reaction3
PECTUS SYSTEM models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PECTUS SYSTEM 01-3710-PPLATE, FIXATION, BONE8 reports
- PECTUS SYSTEM 01-3711PLATE, FIXATION, BONE7 reports
- PECTUS SYSTEM 01-3711-PPLATE, FIXATION, BONE4 reports
- PECTUS SYSTEM 01-3712PLATE, FIXATION, BONE2 reports
- PECTUS SYSTEM 01-3714PLATE, FIXATION, BONE2 reports
- PECTUS SYSTEM 01-3715PLATE, FIXATION, BONE2 reports
- PECTUS SYSTEM PT-3290Plate, Fixation, Bone2 reports
- PECTUS SYSTEM 01-3713PLATE, FIXATION, BONE1 report
- PECTUS SYSTEM 01-3711-05PLATE, FIXATION, BONE1 report
- PECTUS SYSTEM PT-2872Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-2873Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-2871Plate, Fixation, Bone1 report
- PECTUS SYSTEM PS-1279Plate, Fixation, Bone1 report
- PECTUS SYSTEM PS-1352Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3138Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3137Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3339Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3340Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3341Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3452Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3453Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3647Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3648Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3653Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3654Plate, Fixation, Bone1 report
- PECTUS SYSTEM PS-1527Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3697Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3698Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-3926Plate, Fixation, Bone1 report
- PECTUS SYSTEM PS-1636Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-4743Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-4744Plate, Fixation, Bone1 report
- PECTUS SYSTEM PS-1952Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-5223Plate, Fixation, Bone1 report
- PECTUS SYSTEM PT-5236Plate, Fixation, Bone1 report
Recent PECTUS SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Pain; Skin Discoloration
MAUDE report 24661318 ↗InjuryJan 27, 2026Patient Device Interaction Problem
IT WAS REPORTED THE PATIENT DEVELOPED HYPERSENSITIVITY TO THE IMPLANTS APPROXIMATELY THREE MONTHS POST-IMPLANTATION. THE PATIENT EXPERIENCED PAIN AND ITCHING SENSATION. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain
MAUDE report 24189239 ↗InjuryDec 20, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT RECEIVED A PMI PECTUS BAR AND TWO (2) STABILIZERS ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT'S BAR HAD FLIPPED ON AN UNKNOWN DATE POST-IMPLANTATION. PATIENT IS SCHEDULED TO HAVE A REOPERATION ON A UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16015977 ↗InjuryNov 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION FOR THE REMOVAL OF THE PECTUS BAR APPROXIMATELY TWO YEARS FOLLOWING IMPLANTATION DUE TO AN ALLERGIC REACTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 15770482 ↗InjurySep 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE BAR AFTER THE IMPLANT FLIPPED POSITION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 15402172 ↗InjurySep 9, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE CORRECTION OF PECTUS EXCAVATUM APPROXIMATELY EIGHT (8) MONTHS AGO DURING WHICH A PECTUS SUPPORT BAR WAS IMPLANTED. SUBSEQUENTLY, A CT SCAN SHOWED THAT THE BAR SHIFTED AND MAY HAVE ROTATED. A REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE (5) WEEKS AGO TO PLACE A SECOND BAR AND REPOSITION THE FIRST BAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 15396317 ↗InjuryJul 20, 2022Migration; Migration
IT WAS REPORTED THAT DURING A CASE PLANNING THAT IT WAS NOTICED ON A CT SCAN THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A PROCEDURE WITH A BAR BEING IMPLANTED. THE BAR HAD MIGRATED, AND CONSEQUENTLY, THE SURGEON WAS IMPLANTING A SECOND BAR WITH OUT PLANS TO REMOVE THE FIRST BAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15069392 ↗InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR PECTUS EXCAVATUM REPAIR APPROXIMATELY THREE MONTHS AGO AND DURING THE SURGERY HER STERNUM WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 14137383 ↗InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR PECTUS EXCAVATUM REPAIR APPROXIMATELY THREE MONTHS AGO AND DURING THE SURGERY HER STERNUM WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 13758546 ↗InjuryFeb 7, 2022Positioning Failure; Malposition of Device; Positioning Problem; Positioning Failure; Malposition of Device; Positioning Problem
IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION DUE TO DEFECT RECURRENCE AND INCORRECT BAR PLACEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 13472446 ↗InjuryFeb 7, 2022Positioning Failure; Malposition of Device; Positioning Problem; Positioning Failure; Malposition of Device; Positioning Problem
IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION DUE TO DEFECT RECURRENCE AND INCORRECT BAR PLACEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 13472439 ↗InjuryDec 13, 2020Adverse 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: Burning Sensation
MAUDE report 10999108 ↗InjuryDec 13, 2020Adverse 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: Burning Sensation; Erythema; Pain
MAUDE report 10999103 ↗InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A CARDIAC MRI WAS ABANDONED AFTER THE PATIENT EXPERIENCED A BURNING SENSATION AT THE SITE OF THEIR PECTUS SUPPORT BAR. ONE (1) MONTH FOLLOWING IMPLANTATION OF TWO (2) PECTUS SUPPORT BARS, THE PATIENT WENT IN FOR A CARDIAC MRI. THE PATIENT FELT SOME HEATING AFTER THE FIRST LOCALIZER. SOME OTHER QUICKER LOCALIZERS THAT PRODUCE LESS SPECIFIC ABSORPTION RATE WERE ATTEMPTED AND THE PATIENT INDICATED THEY FELT HEATING. THE DECISION WAS MADE TO DISCONTINUE THE SCAN. THE PATIENT INDICATED THAT THE BURNING SENSATION OCCURRED AT THE SIDES OF THE CHEST WHERE THE ENDS OF THE BARS ARE LOCATED, AND THAT THE HEATING OCCURRED ONLY WHEN THE SCANNER WAS ACQUIRING AN IMAGE. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT FOLLOWING THE MRI. THE PATIENT HAS NOT RETURNED FOR A CARDIAC MRI DUE TO HEATING OF THE IMPLANT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Burning Sensation
MAUDE report 10999101 ↗InjuryOct 7, 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: Foreign Body Reaction; Purulent Discharge; Unspecified Infection
MAUDE report 10645099 ↗
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
- 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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