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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO. TRI-CAM INTERNAL IMPLANT; DENTAL IMPLANT
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ACE SURGICAL SUPPLY CO. TRI-CAM INTERNAL IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 305010
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/20/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure (vitoss graft) was performed at the time of surgery.
 
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Brand Name
TRI-CAM INTERNAL IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY CO.
1034 pearl street
brockton MA 02301
MDR Report Key10574456
Report Number1287163-2020-00740
Device Sequence Number14201184
Product Code DZE
UDI-Device Identifier00614950005277
UDI-Public00614950005277
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K103790
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/01/2020
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 Date03/30/2023
Device Model Number305010
Device Catalogue Number305010
Device Lot Number18040002
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/01/2020
Initial Report FDA Received Date09/23/2020
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;
Patient Age57 YR
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