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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S, D.3,3 RN SLACTIVE 8MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S, D.3,3 RN SLACTIVE 8MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 033.131S
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104)
Date of Event 05/30/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2008 in the patient's mouth.On (b)(6) 2019, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
 
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Brand Name
S, D.3,3 RN SLACTIVE 8MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9031933
Report Number0009613348-2019-21462
Device Sequence Number3108849
Product Code DZE
UDI-Device Identifier07630031714763
UDI-Public07630031714763
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/13/2019
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 Date03/31/2013
Device Catalogue Number033.131S
Device Lot NumberK0825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/13/2019
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 Age65 YR
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