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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY TRICAM INTERNAL IMPLANT; DENTAL IMPLANT
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ACE SURGICAL SUPPLY COMPANY TRICAM INTERNAL IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 315010
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Evaluation of the implant determined that all the product's design specifications were met.Visual examination yielded no unusual or specific flaws to the implant design.
 
Event or Problem Description
Inadequate bone quality/bone quantity was reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure (sinus lift) was performed at the time of surgery.
 
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Brand Name
TRICAM INTERNAL IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl street
brockton MA 02301
MDR Report Key8330399
Report Number1287163-2019-00572
Device Sequence Number11028817
Product Code DZE
UDI-Device Identifier00614950007141
UDI-Public00614950007141
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K103790
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/24/2019
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 Model Number315010
Device Catalogue Number315010
Device Lot Number15020094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/24/2019
Initial Report FDA Received Date02/12/2019
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 Age72 YR
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