PECTUS SYSTEM PS-1952Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of PECTUS SYSTEM (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233052184), received between Sep 9, 2022 and Sep 9, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Migration1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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