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Conform Binder Submalar® Size: LargeRecalls & reported problems

Implantech Associates, Inc. · Submalar Implant · 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 M724CBSML1), received between Jun 22, 2018 and Jun 22, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “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

  • Extrusion1

Patient problems

  • Hematoma1

Recent adverse event reports

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

  • InjuryJun 22, 2018Extrusion

    COMPLAINANT REPORTED THAT PATIENT HAD MALAR IMPLANTS EXPLANTED ONE WEEK POST-OPERATIVELY DUE TO BILATERAL EXTRUSION AND HEMATOMA.

    Patient problems: Hematoma

    MAUDE report 7631666 ↗

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.