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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, Ø 3.3 MM, NN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP, Ø 3.3 MM, NN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLA Titanium TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 01/27/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in ada 7.On (b)(6) 2020, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
 
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Brand Name
SP, Ø 3.3 MM, NN, 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 Key10124217
Report Number0001222315-2020-07019
Device Sequence Number19431268
Product Code DZE
UDI-Device Identifier07630031718303
UDI-Public07630031718303
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K010291
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/05/2020
Report Date (Section F) 05/12/2020
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 Date03/31/2011
Device Model NumberSLA Titanium TL
Device Catalogue Number042.933S
Device Lot NumberA7462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/05/2020
Device Age166 MO
Event Location Other
Date Report to Manufacturer05/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/12/2020
Initial Report FDA Received Date06/05/2020
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;
Patient Age77 YR
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