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Malar Implant M 4-3Recalls & reported problems

Hanson Medical, Inc. · Non-sterile, silicone, malar implant, pair. · 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 B049M430), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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

  • Material Protrusion/Extrusion1

Patient problems

  • Discomfort1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 28, 2019Material Protrusion/Extrusion

    PHYSICIAN REPORTED THAT A PATIENT PRESENTED WITH EXTRUSION OF THE LEFT MALAR IMPLANT ON (B)(6) 2019. ORIGINALLY IMPLANTED ON (B)(6) 2019 AFTER WHICH THE PATIENT FELT DISCOMFORT. SUBSEQUENTLY, IMPLANTS WERE REMOVED BILATERAL ON (B)(6) 2019.

    Patient problems: Discomfort

    MAUDE report 8745468 ↗

Other Implant, Malar devices

All Implant, Malar devices →

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