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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 404011
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/07/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be a post-placement/pre-load 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 cannot be performed.
 
Event or Problem Description
Inadequate bone quality/bone quantity was reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was 1 to 5 years after prosthetic restoration.Primary stability and osseointegration was achieved.
 
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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 Key7025997
Report Number1287163-2017-51224
Device Sequence Number1109928
Product Code DZE
UDI-Device Identifier00614950005475
UDI-Public00614950005475
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K954513
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/18/2017
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 Number404011
Device Catalogue Number404011
Device Lot Number12060074
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/18/2017
Initial Report FDA Received Date11/13/2017
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;
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