HANSON MEDICAL MALAR IMPLANT
Received Jun 28, 2019 · Event occurred May 24, 2019
Report 2031444-2019-00001 · MDR key 8745468
Device
Generic name
Malar Implant
Manufacturer
Hanson Medical IncModel number
M 4 - 3Catalog number
M 4 - 3
Lot number
15943
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- Discomfort
- Discomfort
Narrative
Additional Manufacturer Narrative
METHOD: REVIEWED THE COMPLAINT NOTES, DEVICE HISTORY RECORD, RISK ANALYSIS, AND PRODUCT LABELING. RESULTS: REVIEW OF THE COMPLAINT NOTES AND DEVICE HISTORY RECORD REVEALED NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. EXTRUSION IS A KNOWN RISK. PRODUCT LABELING CAUTIONS: "COMPLICATIONS, ALTHOUGH UNCOMMON, INCLUDE INFECTION, EXTRUSION, IMPLANT MOVEMENT, PAIN, ITCHING, IRRITATION, FLUID ACCUMULATION, BLEEDING, BRUISING, AND CAPSULAR CONTRACTURE."
Description of Event or Problem
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.