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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM, CO. NR LINE; DENTAL IMPLANT
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DENTIUM, CO. NR LINE; DENTAL IMPLANT Back to Search Results
Model Number GFX3011S
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/11/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant (b)(4) was removed on (b)(6) 2017 due to failure to osseointegrate 3 months after implantation.The doctor indicated that bone quality may have caused the implant removal.The patient has no significant medical history and has been recovered without complications.
 
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Brand Name
NR LINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM, CO.
#214, 105, gwanggyo-ro
yeoungtung-gu
suwon-si, gyeonggi-do
KS 
MDR Report Key7025338
Report Number3005503242-2017-00117
Device Sequence Number1358360
Product Code DZE
UDI-Device Identifier08809460302356
UDI-Public08809460302356
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K153268
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/13/2017
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 Dentist
Device Expiration Date09/13/2024
Device Model NumberGFX3011S
Device Catalogue NumberGFX3011S
Device Lot Number201609090037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/23/2017
Initial Report FDA Received Date11/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
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