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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.8MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.8MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Roxolid BL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Fibrosis (3167)
Date of Event 11/05/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 18.Details of surgery: primary stability not achieved.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.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
BL,4.8MM RC, SLACT.8MM,ROXOLID,GUIDED
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key11078804
Report Number0001222315-2020-17123
Device Sequence Number2702418
Product Code DZE
UDI-Device Identifier07630031707253
UDI-Public07630031707253
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K121131
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/28/2020
Report Date (Section F) 12/03/2020
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 Date07/23/2023
Device Model NumberSLActive Roxolid BL
Device Catalogue Number021.6308G
Device Lot NumberRL474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/28/2020
Device Age28 MO
Event Location Other
Date Report to Manufacturer12/03/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2020
Initial Report FDA Received Date12/28/2020
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 Age50 YR
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