Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X10MM; ENDOSSEOUS DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X10MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 32141
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/16/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NOBELSPEEDY GROOVY WP 6X10MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB
dimbovgen 2
karlskoga, SE-69 151
SW  SE-69151
MDR Report Key9000466
Report Number9611993-2019-03181
Device Sequence Number3324589
Product Code DZE
UDI-Device Identifier07332747001396
UDI-Public(01)07332747001396(10)12100416(17)221117
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K050406
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) 06/05/2019
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 Date11/17/2022
Device Model Number32141
Device Catalogue Number32141
Device Lot Number12100416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/05/2019
Initial Report FDA Received Date09/11/2019
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 Age60 YR
-
-