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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X8.5MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X8.5MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 32140
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/03/2019
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
NOBELSPEEDY GROOVY WP 6X8.5MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB
dimbovgen 2
karlskoga, SE-69 151
SW  SE-69151
MDR Report Key9052676
Report Number9611993-2019-11830
Device Sequence Number1891200
Product Code DZE
UDI-Device Identifier07332747001389
UDI-Public(01)07332747001389(10)12066459(17)210501
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K050406
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/05/2019
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 Date05/01/2021
Device Model Number32140
Device Catalogue Number32140
Device Lot Number12066459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2019
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;
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