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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CM TITAMAX EX ACQUA IMPL TI 3.5X13; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG CM TITAMAX EX ACQUA IMPL TI 3.5X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 140.663
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/06/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 9.On (b)(6) 2020, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
CM TITAMAX EX ACQUA IMPL TI 3.5X13
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9898632
Report Number0001222315-2020-05423
Device Sequence Number2817928
Product Code DZE
UDI-Device Identifier07899878016755
UDI-Public07899878016755
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/30/2020
Report Date (Section F) 03/16/2020
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 Date01/23/2017
Device Model Number140.663
Device Catalogue Number140.663
Device Lot Number800172134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/30/2020
Device Age97 MO
Event Location Other
Date Report to Manufacturer03/16/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2020
Initial Report FDA Received Date03/30/2020
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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