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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP IMPL., 4.8MM RN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP IMPL., 4.8MM RN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Abscess (1690); Unspecified Infection (1930); Pain (1994)
Date of Event 04/15/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in ada 5.On (b)(6) 2021, loss of osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain and abscess.No further patient complications were reported.
 
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Brand Name
SP IMPL., 4.8MM RN, SLACTIVE 14MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key11993092
Report Number0001222315-2021-09809
Device Sequence Number14256671
Product Code DZE
UDI-Device Identifier07630031714978
UDI-Public07630031714978
Combination Product (Y/N)N
Initial Reporter StateME
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/14/2021
Report Date (Section F) 05/20/2021
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 Date12/31/2014
Device Model NumberSLActive Titanium TL
Device Catalogue Number033.254S
Device Lot NumberX4631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/14/2021
Device Age136 MO
Event Location Other
Date Report to Manufacturer05/20/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/14/2021
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;
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