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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SLACTIVE® GI BL Ø 4.1 MM RC 12 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SLACTIVE® GI BL Ø 4.1 MM RC 12 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 021.4112G
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/22/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in fdi 45.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
SLACTIVE® GI BL Ø 4.1 MM RC 12 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9092114
Report Number0009613348-2019-02369
Device Sequence Number19506835
Product Code DZE
UDI-Device Identifier07630031706812
UDI-Public07630031706812
Combination Product (Y/N)N
PMA/510(K) Number
K090260
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) 09/19/2019
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 Date07/14/2019
Device Catalogue Number021.4112G
Device Lot NumberHK147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/19/2019
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 Age55 YR
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