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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S, Ø 4.8 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S, Ø 4.8 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 043.234S
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/16/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Report late due to asr to individual reporting transition per fda letter dated june 28, 2019.
 
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 4.8 MM, RN, SLA 14.0 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9229100
Report Number0009613348-2019-36710
Device Sequence Number2233451
Product Code DZE
UDI-Device Identifier07630031718860
UDI-Public07630031718860
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) 10/23/2019
Report Date (Section F) 05/20/2019
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 Catalogue Number043.234S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/24/2019
Event Location Other
Date Report to Manufacturer05/20/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/20/2019
Initial Report FDA Received Date10/23/2019
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;
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