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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 4.0X17; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG CM TITAMAX EX ACQUA IMPL TI 4.0X17; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 140.640
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Fistula (1862); Pain (1994); Swelling (2091)
Date of Event 12/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2016 in ada 23.On (b)(6) 2019, loss of osseointegration was verified.Patient presented with bone type iv.The device was forwarded to the manufacturer.At the event the patient experienced: pain, swelling and fistula.No further patient complications were reported.
 
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Brand Name
CM TITAMAX EX ACQUA IMPL TI 4.0X17
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9613649
Report Number0001222315-2020-00888
Device Sequence Number14133391
Product Code DZE
UDI-Device Identifier07899878016595
UDI-Public07899878016595
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/21/2020
Report Date (Section F) 01/07/2020
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 Date04/01/2017
Device Model Number140.640
Device Catalogue Number140.640
Device Lot Number800183290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/22/2020
Device Age92 MO
Event Location Other
Date Report to Manufacturer01/07/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date01/21/2020
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;
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