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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 305011
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Swelling (2091)
Date of Event 02/23/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from procedural errors.Correct use and procedural instructions are described in this product's instructions for use.
 
Event or Problem Description
Swelling and inadequate bone quality/bone quantity were reported.Time of loss in relation to the implantation was before prosthetic restoration.Bone quality at the time of implant failure was type iii.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was performed (freeze dried demineralized bone).
 
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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 Key7710703
Report Number1287163-2018-00470
Device Sequence Number1528363
Product Code DZE
UDI-Device Identifier00614950005284
UDI-Public00614950005284
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K103790
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/03/2018
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 Number305011
Device Catalogue Number305011
Device Lot Number16050053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/03/2018
Initial Report FDA Received Date07/23/2018
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 Age66 YR
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