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Binder Submalar® Size: MediumRecalls & 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 M724BSMM1), received between Oct 6, 2017 and Oct 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (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

  • Contamination1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryOct 6, 2017Contamination

    COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF LEFT CHEEK TENDERNESS AND HAD LEFT SIDE CHEEK IMPLANT EXPLANTED DUE TO INFECTION APPROXIMATELY 3 MONTHS POST-OPERATIVELY. NO CULTURE WAS TAKEN, SO NO ORGANISM HAS BEEN IDENTIFIED. AS OF (B)(6) 2017, PHYSICIAN FELT INFECTION APPEARS TO BE RESOLVED. NOTE: THE COMPLAINANT REPORTED THAT RHINOPLASTY, NECK LIFT, LIP LIFT, MANDIBLE AND FOREHEAD CONTOURING WITH BROW LIFT AND SCALP ADVANCEMENT WERE CITED AS CONCOMITANT MEDICAL THERAPIES.

    Patient problems: Unspecified Infection

    MAUDE report 6923692 ↗

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.