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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE, Ø 3.3 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG TE, Ø 3.3 MM, RN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 043.724S
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 06/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2010 in the patient's mouth.Details of surgery: sinus augmentation.On (b)(6) 2019, loss of osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
TE, Ø 3.3 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 Key9034229
Report Number0009613348-2019-07295
Device Sequence Number2593971
Product Code DZE
UDI-Device Identifier07630031701060
UDI-Public07630031701060
Combination Product (Y/N)N
Initial Reporter CountryKR
PMA/510(K) Number
K012757
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/13/2019
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 Number043.724S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/13/2019
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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