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NA SD480.100Recalls & reported problems

Synthes GmbH · TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.5MM THICK · Class 2 · Implant

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 10887587005294), received between Aug 7, 2023 and Aug 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • InjuryAug 7, 2023Break; Break

    IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN (B)(6)2023 WHEN THE PLATE BROKE. THE BONE OF THE JAW HAD HEALED, BUT THE CORNER PART HAD NOT COMPLETELY HEALED. THERE WERE NO LOADS APPLIED. AFTER THE REVISION SURGERY ON (B)(6)2023, THE PATIENT WAS REPORTED TO BE DOING WELL.

    Patient problems: Failure of Implant

    MAUDE report 17471091 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.