MAUDE Adverse Event Report: DENTIUM CO., LTD NR LINE; DENTAL IMPLANT

Model Number	GFX3013S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	09/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per doctor, the implant was removed due to osseointegration failure within 1 year, approximately 6 months after implant placement.Bone quality around the area was type ii, and oral hygiene around the implant was good.No significant findings were observed during the implant removal surgery.Bone augmentation material was not used on implant placement surgery.The patient has insufficient bone.

• Brand Name: NR LINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM CO., LTD; 76, changyong-daero; 256 beongil yeontong-gu; suwan-si, gyeoggido 16229 ; KS 16229
• Manufacturer (Section G): DENTIUM CO., LTD; 76, changyong-daero; 256 beongil yeontong-gu; suwan-si, gyeoggido 16229 ; KS 16229
• Manufacturer Contact: eun son ; 76, changyon-daero; 256 beongil yeontong-gu; suwan-si, gyeoggido 16229 ; KS 16229
• MDR Report Key: 15845558
• Report Number: 3005503242-2022-00108
• Device Sequence Number: 20331977
• Product Code: DZE
• UDI-Device Identifier: 08809460302370
• UDI-Public: 08809460302370
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K153268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Model Number: GFX3013S
• Device Catalogue Number: GFX3013S
• Device Lot Number: 201609090038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female