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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INFINITY IMPLANT SYSTEM; TRICAM PLATFORM TAPERED
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ACE SURGICAL SUPPLY COMPANY INFINITY IMPLANT SYSTEM; TRICAM PLATFORM TAPERED Back to Search Results
Model Number 305013
Device Problems Failure to Interrogate (1332); Implant, removal of (2320); Implant Mobility NOS (Not otherwise specified) (2645)
Patient Problem Failure of Implant (1924)
Event Date 12/13/2013
Event Type  Injury  
Event Description
Dental implant failed to integrate - mobility.Bone quality at time of failure type ii.Primary stability and osseointegration were not achieved.Grafting material used porous bone.Site location 5.Implant date (b)(6) 2013, removed (b)(6) 2013.
 
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Brand Name
INFINITY IMPLANT SYSTEM
Type of Device
TRICAM PLATFORM TAPERED
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
brockton MA
Manufacturer Contact
1034 pearl st.
brockton, MA 02301
8004413100
MDR Report Key3642073
MDR Text Key4353897
Report Number1287163-2014-00006
Device Sequence Number1
Product Code DZE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Remedial Action Replace
Type of Report Initial
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2017
Device Model Number305013
Device Catalogue Number305013
Device Lot Number12030105
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/16/2014
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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