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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S, Ø 4.8 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S, Ø 4.8 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 043.234S
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/12/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2001 in ada 5.On (b)(6) 2019, loss of osseointegration was verified.Patient presented with bone type iii and fair oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis.No further patient complications were reported.
 
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Brand Name
S, Ø 4.8 MM, RN, SLA 14.0 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9584231
Report Number0009613348-2020-02536
Device Sequence Number10856296
Product Code DZE
UDI-Device Identifier07630031718860
UDI-Public07630031718860
Combination Product (Y/N)N
Initial Reporter StateDE
Initial Reporter CountryUS
PMA/510(K) Number
K983742
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2001
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
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 Expiration Date01/31/2005
Device Catalogue Number043.234S
Device Lot Number1007
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
Device Age239 MO
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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