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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, 3.3 MM, RN, SLACTIVE 14.0 MM, TIZR; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP, 3.3 MM, RN, SLACTIVE 14.0 MM, TIZR; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Roxolid TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Pain (1994); Fibrosis (3167)
Date of Event 10/29/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 23.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2020, loss of osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
 
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Brand Name
SP, 3.3 MM, RN, SLACTIVE 14.0 MM, TIZR
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key12319885
Report Number0001222315-2021-13278
Device Sequence Number4301199
Product Code DZE
UDI-Device Identifier07630031715692
UDI-Public07630031715692
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/13/2021
Report Date (Section F) 07/20/2021
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 Date05/31/2016
Device Model NumberSLActive Roxolid TL
Device Catalogue Number033.454S
Device Lot NumberAT185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/13/2021
Device Age113 MO
Event Location Other
Date Report to Manufacturer07/20/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/13/2021
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 Age68 YR
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