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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 09270705
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/03/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be a post-placement/pre-load implant failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors and/or the lack of osseointegration.Additionally, other factors that may have contributed to the implant failure includes bone condition, patient oral hygiene, or patient behavior.Proper intended use of the implant is described in its instructions for use.Physical analysis was not performed.
 
Event or Problem Description
Doctor states the implant stops within the bone.He also states part of the implant buried in the bone is not extruded.
 
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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 Key6133379
Report Number1287163-2016-50749
Device Sequence Number1155106
Product Code DZE
UDI-Device Identifier00614950002887
UDI-Public00614950002887
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K073343
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/18/2016
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 Number09270705
Device Catalogue Number09270705
Device Lot Number12060039
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/18/2016
Initial Report FDA Received Date11/29/2016
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 Age66 YR
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