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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S Ø 4.8MM RN, SLA® 14MM, TI, LOXIM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S Ø 4.8MM RN, SLA® 14MM, TI, LOXIM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLA Titanium TL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 10/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth.On (b)(6) 2019, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
S Ø 4.8MM RN, SLA® 14MM, TI, LOXIM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9614068
Report Number0009613348-2020-04561
Device Sequence Number2416659
Product Code DZE
UDI-Device Identifier07630031719720
UDI-Public07630031719720
Combination Product (Y/N)N
Initial Reporter CountryKR
PMA/510(K) Number
K983742
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) 01/21/2020
Report Date (Section F) 01/07/2020
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 Model NumberSLA Titanium TL
Device Catalogue Number043.938S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/22/2020
Event Location Other
Date Report to Manufacturer01/07/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date01/21/2020
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;
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