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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S,Ø4.1MM RN, SLACT.10MM,ROXOLID,GUIDATO; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S,Ø4.1MM RN, SLACT.10MM,ROXOLID,GUIDATO; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 033.532G
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 11/21/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in fdi 14, failure occurred upon insertion.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
S,Ø4.1MM RN, SLACT.10MM,ROXOLID,GUIDATO
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9584112
Report Number0009613348-2020-02482
Device Sequence Number19644460
Product Code DZE
UDI-Device Identifier07630031715869
UDI-Public07630031715869
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K122855
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/13/2020
Report Date (Section F) 12/30/2019
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 Catalogue Number033.532G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/14/2020
Event Location Other
Date Report to Manufacturer12/30/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/13/2020
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;
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