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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY MINIMARK; DENTAL IMPLANT
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ACE SURGICAL SUPPLY COMPANY MINIMARK; DENTAL IMPLANT Back to Search Results
Model Number 10231320
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/15/2016
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
Time of loss in relation to the implantation was up to 1 yr after prosthetic restoration.Primary stability was achieved but osseointegration was not achieved.Swelling and mobility was reported.Bone quality at the time of implant failure was type iii.It was reported implant was loose and not healing.Implant lifted out of the site without doctor having to apply any force or use of instruments.Patient has diabetes.
 
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Brand Name
MINIMARK
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl street
brockton MA 02301
MDR Report Key5528775
Report Number1287163-2016-00210
Device Sequence Number10849859
Product Code DZE
UDI-Device Identifier00614950003082
UDI-Public00614950003082
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K092594
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/29/2016
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 Number10231320
Device Catalogue Number10231320
Device Lot Number14050042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/29/2016
Initial Report FDA Received Date03/28/2016
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 Age71 YR
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