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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG GM TITAMAX ACQUA IMPLANT,TI,5.0X11; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG GM TITAMAX ACQUA IMPLANT,TI,5.0X11; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.923
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 10/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 26.On (b)(6) 2019, non-osseointegration was verified.Patient presented with bone type iii and fair oral hygiene.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
GM TITAMAX ACQUA IMPLANT,TI,5.0X11
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9448114
Report Number0001222315-2019-13540
Device Sequence Number2208124
Product Code DZE
UDI-Device Identifier07899878024866
UDI-Public07899878024866
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K163194
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/10/2019
Report Date (Section F) 11/13/2019
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 Expiration Date06/22/2019
Device Catalogue Number140.923
Device Lot Number800307250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/11/2019
Device Age64 MO
Event Location Other
Date Report to Manufacturer11/13/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2019
Initial Report FDA Received Date12/10/2019
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 Age75 YR
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