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

Model Number	GFX3011S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure within 1 year, approximately 4 months after implant placement.Bone quality around the area was type iii, and oral hygiene around the implant was good.The doctor reported no significant findings during the implant removal surgery.Bone was grafted at surgery location and patient will retry implant placement at a future date.
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure within 1 year, approximately 4 months after implant placement.Bone quality around the area was type iii, and oral hygiene around the implant was good.The doctor reported no significant findings during the implant removal surgery.Bone was grafted at surgery location and patient will retry implant placement at a future date.
Additional Manufacturer Narrative
Please see attached summary memo.

• 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: 13573293
• Report Number: 3005503242-2022-00007
• Device Sequence Number: 20215477
• Product Code: DZE
• UDI-Device Identifier: D755FX3610SWC0
• UDI-Public: D755FX3610SWC0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 02/21/2022

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 Model Number: GFX3011S
• Device Catalogue Number: FX3610SWC
• Device Lot Number: R02006151040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2020
• 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: 65 YR
• Patient Sex: Female