2.4MM STERNALOCK (TM) SYSTEM 71-6410Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
Data updated Oct 18, 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 00841036075606), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT ONE STERNAL PLATE FRACTURED AND SCREWS BACKED OUT OF A PLATE SEVEN MONTHS POST-OPERATIVELY. IN (B)(6) 2019, THREE PLATES AND TEN SCREWS WERE IMPLANTED IN A RAVITCH PROCEDURE CORRECTING PECTUS EXCAVATUM. IN (B)(6) 2019, THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW PLATES AND SCREWS. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE REVISION SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Information
MAUDE report 9577866 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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