Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY MINIMARK; DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ACE SURGICAL SUPPLY COMPANY MINIMARK; DENTAL IMPLANT Back to Search Results
Model Number 10231040
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/26/2015
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 and mobility was reported.Primary stability was achieved but osseointegration was not.Augmentation procedure was not performed at the time of surgery.Patient is a smoker.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINIMARK
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl street
brockton MA 02301
MDR Report Key5564134
Report Number1287163-2016-00215
Device Sequence Number13530352
Product Code DZE
UDI-Device Identifier00614950003051
UDI-Public00614950003051
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K092594
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/14/2016
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 Number10231040
Device Catalogue Number10231040
Device Lot Number12110011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2016
Initial Report FDA Received Date04/08/2016
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 Age80 YR
-
-