PECTUS BLU (TM) 78-8020Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888233032834), received between Feb 5, 2025 and Feb 11, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Migration1
Patient problems
- Discomfort1
- Extraskeletal ossification1
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PECTUS REPAIR PROCEDURE. APPROXIMATELY TWO MONTHS POST-IMPLANTATION DURING A ROUTINE CHECKUP, THE SURGEON DISCOVERED DISPLACEMENT OF THE BAR HAD OCCURRED, AND THE PRODUCT MIGRATED INTO THE CHEST CAVITY. THE PATIENT EXPERIENCED DISCOMFORT DUE TO THE EVENT. THEREFORE, THE PATIENT UNDERWENT A PROCEDURE TO REPOSITION THE BAR. DURING REOPERATION, THE DEVICE WAS REPOSITIONED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADDITIONAL DEVICES BEING IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 24313951 ↗InjuryMar 3, 2025Adverse 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: Post Operative Wound Infection
MAUDE report 21503968 ↗InjuryFeb 5, 2025Adverse 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: Extraskeletal ossification
MAUDE report 21316045 ↗
Other Plate, fixation, bone devices
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- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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