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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THOMMEN MEDICAL AG CONTACT RC INICELL; DENTAL IMPLANT

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THOMMEN MEDICAL AG CONTACT RC INICELL; DENTAL IMPLANT Back to Search Results
Model Number 4.23.223
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 02/19/2018
Event Type  Injury  
Event Description
General dentist didn't follow instructions and loaded implant too early.Also trauma or accident was indicated.
 
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Brand Name
CONTACT RC INICELL
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
THOMMEN MEDICAL AG
neckarsulmstrasse 28
2540 grenchen
grenchen, switzerland
SZ 
MDR Report Key7367188
MDR Text Key103353728
Report Number3003708589-2018-00055
Device Sequence Number1
Product Code DZE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/22/2018,03/01/2018
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
Device Operator Dentist
Device Expiration Date05/11/2022
Device Model Number4.23.223
Device Catalogue Number4.23.223
Device Lot Number15801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2018
Distributor Facility Aware Date03/16/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/19/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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