MalfunctionODU
MICROAIRE ENDOTINE
Received Feb 3, 2023 · Event occurred Jan 6, 2023
Report 2020601-2023-00001 · MDR key 16296369
Device
Generic name
Endotine Forehead 3.0
Manufacturer
Microaire Surgical Instruments, LlcModel number
CFD-22202Catalog number
CFD-22202
Lot number
374038
Product problems
- Deformation Due to Compressive Stress
- Deformation Due to Compressive Stress
Patient
40 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER STATES THAT A FEMALE PATIENT WAS IMPLANTED WITH CFD-22202 LOT # 374038 ON (B)(6) 2022. THE PATIENT RETURNED TO THE CLINIC FOR A POST-OPERATIVE APPOINTMENT ON (B)(6) 2023 AND THE DOCTOR STATED THAT THE SURGICAL SITE DID NOT FEEL NORMAL. AT THAT TIME THE DOCTOR RE-OPENED THE SURGICAL SITE AND IDENTIFIED THAT THE TINES OF THE IMPLANT WERE BROKEN ON THE IMPLANT AND THE DOCTOR REMOVED THE ORIGINAL (COMPLAINT) IMPLANT AND PLACED ANOTHER IMPLANT WITHIN THE SURGICAL SITE.