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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 4.8 MM RC, SLACT. 10 MM, GUIDATA; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL, Ø 4.8 MM RC, SLACT. 10 MM, GUIDATA; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 021.6110G
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 08/12/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2015 in fdi 16.On (b)(6) 2019, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
BL, Ø 4.8 MM RC, SLACT. 10 MM, GUIDATA
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9430661
Report Number0009613348-2019-48299
Device Sequence Number1672030
Product Code DZE
UDI-Device Identifier07630031707208
UDI-Public07630031707208
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K090260
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/06/2019
Report Date (Section F) 11/14/2019
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 Expiration Date09/30/2015
Device Catalogue Number021.6110G
Device Lot NumberZ6191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/06/2019
Device Age107 MO
Event Location Other
Date Report to Manufacturer11/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/06/2019
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;
Patient Age52 YR
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