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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,Ø4.8MM RC, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL,Ø4.8MM RC, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 021.6310G
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 03/26/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 in ada 14 of the patient's mouth.Details of surgery: implant surface not completely covered with bone.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
BL,Ø4.8MM RC, 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 Key9017075
Report Number0009613348-2019-26684
Device Sequence Number1748629
Product Code DZE
UDI-Device Identifier07630031707277
UDI-Public07630031707277
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K121131
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/12/2019
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 Date11/15/2021
Device Catalogue Number021.6310G
Device Lot NumberML049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
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 Age68 YR
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