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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 4.0X13; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG CM TITAMAX EX ACQUA IMPL TI 4.0X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.638
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in ada 13.On (b)(6) 2019, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
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Brand Name
CM TITAMAX EX ACQUA IMPL TI 4.0X13
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9533010
Report Number0001222315-2019-15004
Device Sequence Number2314662
Product Code DZE
UDI-Device Identifier07899878016571
UDI-Public07899878016571
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/30/2019
Report Date (Section F) 12/16/2019
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 Date08/22/2018
Device Catalogue Number140.638
Device Lot Number800227675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/30/2019
Device Age76 MO
Event Location Other
Date Report to Manufacturer12/16/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/16/2019
Initial Report FDA Received Date12/30/2019
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 Age71 YR
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