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U.S. Department of Health and Human Services

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

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THOMMEN MEDICAL AG CONTACT MC INICELL; DENTAL IMPLANT Back to Search Results
Model Number 4.23.634
Device Problems Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 11/02/2017
Event Type  Injury  
Event Description
Pain.Implant was mobile.Failure to integrate due to smoking.
 
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Brand Name
CONTACT MC INICELL
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
THOMMEN MEDICAL AG
neckarsulmstrasse 28
2540 grenchen, sz
SZ 
MDR Report Key7267594
MDR Text Key99952809
Report Number3003708589-2018-00028
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 02/12/2018,11/23/2017
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 Date07/27/2021
Device Model Number4.23.634
Device Catalogue Number4.23.634
Device Lot Number14394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2018
Distributor Facility Aware Date01/30/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/05/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
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