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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT LLC INTERACTIVE® IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT LLC INTERACTIVE® IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 653210
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 10/27/2017
Event Type  malfunction  
Event Description
The abutment would not disconnect from the implant.The implant was removed as a result.
 
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Brand Name
INTERACTIVE® IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT LLC
3050 e hillcrest dr.
thousand oaks CA 91362
Manufacturer (Section G)
IMPLANT DIRECT LLC
3050 e hillcrest dr.
thousand oaks CA 91362
Manufacturer Contact
evan garner
3050 e hillcrest dr.
thousand oaks, CA 91362
8184443300
MDR Report Key7148593
MDR Text Key95865002
Report Number3001617766-2017-00115
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307100331
UDI-Public10841307100331
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Dentist
Type of Report Initial
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Expiration Date01/20/2022
Device Model Number653210
Device Catalogue Number653210
Device Lot Number88730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2017
Initial Date FDA Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2017
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 Age41 YR
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