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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,Ø4.8MM RC, SLACT.8MM,ROXOLID,GEFÜHRT; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL,Ø4.8MM RC, SLACT.8MM,ROXOLID,GEFÜHRT; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Roxolid BL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in fdi 17.On (b)(6) 2019, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
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Brand Name
BL,Ø4.8MM RC, SLACT.8MM,ROXOLID,GEFÜHRT
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9684569
Report Number0009613348-2020-08510
Device Sequence Number3445626
Product Code DZE
UDI-Device Identifier07630031707253
UDI-Public07630031707253
Combination Product (Y/N)N
Initial Reporter CountryDE
PMA/510(K) Number
K121131
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/07/2020
Report Date (Section F) 01/24/2020
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 Date09/04/2021
Device Model NumberSLActive Roxolid BL
Device Catalogue Number021.6308G
Device Lot NumberMC356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2020
Device Age39 MO
Event Location Other
Date Report to Manufacturer01/24/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/24/2020
Initial Report FDA Received Date02/07/2020
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 Age56 YR
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