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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.10MM,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 No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/08/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 19.On (b)(6) 2021, non-osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
BL,4.8MM RC, SLACT.10MM,ROXOLID,GUIDED
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key11344424
Report Number0001222315-2021-02651
Device Sequence Number19669923
Product Code DZE
UDI-Device Identifier07630031707277
UDI-Public07630031707277
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K121131
Summary Report (Y/N)Y
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/18/2021
Report Date (Section F) 01/25/2021
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 Date06/28/2023
Device Model NumberSLActive Roxolid BL
Device Catalogue Number021.6310G
Device Lot NumberRL860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/18/2021
Device Age31 MO
Event Location Other
Date Report to Manufacturer01/25/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2021
Initial Report FDA Received Date02/18/2021
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 Age73 YR
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