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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY EXTERNAL HEX IMPLANT; DENTAL IMPLANT
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ACE SURGICAL SUPPLY COMPANY EXTERNAL HEX IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 404713
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/16/2016
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 before restoration.Primary stability was achieved but osseointegration was not.Achieved.Asymptomatic and mobility was reported.Pain also was reported.Augmentation procedure was not performed at the time of surgery.Bone quality at the time of implant failure was type iii.
 
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Brand Name
EXTERNAL HEX IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl street
brockton MA 02301
MDR Report Key5488975
Report Number1287163-2016-00209
Device Sequence Number10861807
Product Code DZE
UDI-Device Identifier00614950005536
UDI-Public00614950005536
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K954513
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) 02/23/2016
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 Number404713
Device Catalogue Number404713
Device Lot Number13030144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/23/2016
Initial Report FDA Received Date03/09/2016
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 Age48 YR
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