PECTUS SYSTEM 01-3710-PRecalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841036076221), received between Sep 25, 2020 and Sep 30, 2020 — classified as 8 injuries.
The most frequently reported specific device problem is “Migration” (2 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
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Migration2
Patient problems
- Pneumothorax6
- Failure of Implant2
- No Information2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED A PNEUMOTHORAX AND UNDERWENT EMERGENCY SURGERY FORTY-TWO (42) DAYS FOLLOWING IMPLANTATION OF FOUR (4) PECTUS SUPPORT BARS AND FOURTEEN (14) DAYS FOLLOWING A REVISION TO CORRECT DEVICE MIGRATION OF THE PECTUS SUPPORT BARS. THE POSITION OF DEVICES WAS NOT MODIFIED DURING THE EMERGENCY SURGERY FOR THE PNEUMOTHORAX. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 10608050 ↗InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED A PNEUMOTHORAX AND UNDERWENT EMERGENCY SURGERY FORTY-TWO (42) DAYS FOLLOWING IMPLANTATION OF FOUR (4) PECTUS SUPPORT BARS AND FOURTEEN (14) DAYS FOLLOWING A REVISION TO CORRECT DEVICE MIGRATION OF THE PECTUS SUPPORT BARS. THE POSITION OF DEVICES WAS NOT MODIFIED DURING THE EMERGENCY SURGERY FOR THE PNEUMOTHORAX. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 10608030 ↗InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED A PNEUMOTHORAX AND UNDERWENT EMERGENCY SURGERY FORTY-THREE (43) DAYS FOLLOWING IMPLANTATION OF FOUR (4) PECTUS SUPPORT BARS, FOURTEEN (14) DAYS FOLLOWING A REVISION TO CORRECT DEVICE MIGRATION OF THE PECTUS SUPPORT BARS, AND ONE (1) DAY FOLLOWING AN ADDITIONAL SURGERY DUE TO PNEUMOTHORAX. THE POSITION OF DEVICES WAS NOT MODIFIED DURING THE EMERGENCY SURGERIES FOR THE PNEUMOTHORAX. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 10606637 ↗InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED A PNEUMOTHORAX AND UNDERWENT EMERGENCY SURGERY FORTY-THREE (43) DAYS FOLLOWING IMPLANTATION OF FOUR (4) PECTUS SUPPORT BARS, FOURTEEN (14) DAYS FOLLOWING A REVISION TO CORRECT DEVICE MIGRATION OF THE PECTUS SUPPORT BARS, AND ONE (1) DAY FOLLOWING AN ADDITIONAL SURGERY DUE TO PNEUMOTHORAX. THE POSITION OF DEVICES WAS NOT MODIFIED DURING THE EMERGENCY SURGERIES FOR THE PNEUMOTHORAX. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 10606617 ↗InjurySep 28, 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: Pneumothorax
MAUDE report 10593152 ↗InjurySep 28, 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: Pneumothorax
MAUDE report 10593148 ↗InjurySep 25, 2020Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Information
MAUDE report 10587390 ↗InjurySep 25, 2020Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Information
MAUDE report 10587378 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.