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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELACTIVE TIULTRA NP 3.5X10MM; ENDOSSEOUS DENTAL IMPLANT

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NOBEL BIOCARE USA INC NOBELACTIVE TIULTRA NP 3.5X10MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 300245
Device Problem Defective Device (2588)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 02/01/2023
Event Type  Injury  
Event Description
Implant failed due to a part not functional.
 
Manufacturer Narrative
The initial report did not have the correct event type documented, the correct event type, injury, is provided in this follow up report.
 
Event Description
The initial report did not have the correct event type documented, the correct event type, injury, is provided in this follow up report.
 
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Brand Name
NOBELACTIVE TIULTRA NP 3.5X10MM
Type of Device
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE USA INC
22725 savi ranch
yorba linda CA 92887 4609
Manufacturer (Section G)
NOBEL BIOCARE USA INC
22725 savi ranch
yorba linda CA 92887 4609
Manufacturer Contact
gayco meel
popeweg 72
venlo 5928 -SC
NL   5928 SC
623202508
MDR Report Key16726877
MDR Text Key313158244
Report Number2027971-2023-062986
Device Sequence Number1
Product Code DZE
UDI-Device Identifier07332747127362
UDI-Public(01)07332747127362(10)13139823(17)271002
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
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? Yes
Device Operator Health Professional
Device Model Number300245
Device Catalogue Number300245
Device Lot Number13139823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/08/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient SexPrefer Not To Disclose
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