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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP,Ø4.8MM RN, SLACT.8MM,ROXOLID,GUIDÉE; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP,Ø4.8MM RN, SLACT.8MM,ROXOLID,GUIDÉE; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 033.591G
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 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: mobility.No further patient complications were reported.
 
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Brand Name
SP,Ø4.8MM RN, SLACT.8MM,ROXOLID,GUIDÉE
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9007286
Report Number0009613348-2019-00580
Device Sequence Number14108918
Product Code DZE
UDI-Device Identifier07630031716132
UDI-Public07630031716132
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K122855
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/12/2019
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 Date11/28/2021
Device Catalogue Number033.591G
Device Lot NumberML753
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/12/2019
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 Age72 YR
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