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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 303516
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Date of Event 02/10/2017
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
Pain, swelling, mobility, infection and fistula was reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was not achieved.Augmentation was performed at time of surgery.Also reported the patient has hypertension and steven johnson syndrome.
 
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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 Key6375902
Report Number1287163-2017-00314
Device Sequence Number759916
Product Code DZE
UDI-Device Identifier00614950005208
UDI-Public00614950005208
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K103790
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/17/2017
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 Dentist
Device Model Number303516
Device Catalogue Number303516
Device Lot Number15050108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/17/2017
Initial Report FDA Received Date03/03/2017
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 Age73 YR
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