MICROAIRE ENDOTINE
Received Feb 19, 2021 · Event occurred Jan 11, 2021
Report 2020601-2021-00001 · MDR key 11350576
Device
Generic name
Endotine Forehead 3.5
Manufacturer
Microaire Surgical InstrumentsModel number
CFD-22102Catalog number
CFD-22102
Lot number
351185
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
50 YR · Female
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ENDOTINE FOREHEAD 3.5 LOT 3 351185 WAS PLACED ON (B)(6) 2022 DID NOT HOLD THE SOFT TISSUE SECURELY AND TIGHTLY. DOCOTR FOUND THAT THE IMPLANT DID NOT HOLD THE SOFT TISSUE SECURELY. IT MEANT THAT THE FIXATION WAS LOOSE AND PATIENT REQUESTED A RE-DO PROCEDURE AND IMPLANTED ANOTHER 22102 LOT # 354742 ON (B)(6) 2021 AND THE OPERATION WAS DONE SUCCESSFULLY.
Description of Event or Problem
ENDOTINE FOREHEAD 3.5 LOT 351185 WAS PLACED ON (B)(6) 2020 DID NOT HOLD THE SOFT TISSUE SECURELY AND TIGHTLY. DOCOTR FOUND THAT THE IMPLANT DID NOT HOLD THE SOFT TISSUE SECURELY. IT MEANT THAT THE FIXATION WAS LOOSE AND PATIENT REQUESTED A RE-DO PROCEDURE AND IMPLANTED ANOTHER 22102 LOT # 354742 ON (B)(6) 2021 AND THE OPERATION WAS DONE SUCCESSFULLY.
Description of Event or Problem
THE FEMALE PATIENT HAD A CFD-22102 ENDOTINE FOREHEAD 3.5 LOT # 351185 IMPLANTED ON (B)(6) 2020 AND LATER FOUND THAT THE IMPLANT DID NOT HOLD THE SOFT TISSUE SECURELY. CUSTOMER STATES THEY FEEL THE FIXATION WAS LOOSE AND REQUESTED A REVISION OF THE PROCEDURE.
Remedial action
- Replace