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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE-IMPLANT Ø4.1MM, WN, SLACTIVE, 12.0MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG TE-IMPLANT Ø4.1MM, WN, SLACTIVE, 12.0MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 80495S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 07/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 5 of the patient's mouth, 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
TE-IMPLANT Ø4.1MM, WN, SLACTIVE, 12.0MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9040091
Report Number0009613348-2019-22055
Device Sequence Number11418743
Product Code DZE
UDI-Device Identifier07630031727596
UDI-Public07630031727596
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
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 Date06/06/2021
Device Catalogue Number80495S
Device Lot NumberLM891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
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 Age79 YR
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