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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP,Ø4.8MM RN, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP,Ø4.8MM RN, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 033.592G
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports, that the implant was inserted (b)(6) 2019 in ada 20 of the patient's mouth.Details of surgery are reported as follows: implant surface was not completely covered with bone.On (b)(6) 2019, non-osseointegration of the implant was verified.The device was forwarded to the manufacturer for investigation.There were no reported patient injuries or complications.
 
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Brand Name
SP,Ø4.8MM RN, 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 Key9014493
Report Number0001222315-2019-06259
Device Sequence Number19464993
Product Code DZE
UDI-Device Identifier07630031716156
UDI-Public07630031716156
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K122855
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/09/2019
Report Date (Section F) 06/06/2019
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 Date05/15/2019
Device Catalogue Number033.592G
Device Lot NumberHC096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/13/2019
Device Age59 MO
Event Location Other
Date Report to Manufacturer06/06/2019
Initial Date Received by Manufacturer 06/06/2019
Initial Report FDA Received Date09/12/2019
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 Age56 YR
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