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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC REPLACE SELECT TAPERED TIU 6.0 6.0X8MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE USA, LLC REPLACE SELECT TAPERED TIU 6.0 6.0X8MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 36110
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event 05/29/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).Revoked asr exemption number e1997036 'report late due to asr to individual reporting transition'.
 
Event or Problem Description
Implant failed due to failure to osseointegrate.
 
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Brand Name
REPLACE SELECT TAPERED TIU 6.0 6.0X8MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE USA, LLC
22715 savi ranch parkway
yorba linda CA 92887 7149
MDR Report Key9053002
Report Number2027971-2019-11831
Device Sequence Number13992250
Product Code DZE
UDI-Device Identifier07332747022629
UDI-Public(01)07332747022629(10)13057051(17)221126
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K023113
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/13/2019
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 Date11/26/2022
Device Model Number36110
Device Catalogue Number36110
Device Lot Number13057051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2019
Initial Report FDA Received Date09/14/2019
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 Age44 YR
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