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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 404010
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/10/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be an unsuccessful placement implant failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors.Physical analysis was not performed.
 
Event or Problem Description
Mobility and no osseointegration was reported.Time of loss in relation to the implantation was 0-3 months before discovery.Bone quality at the time of implant failure 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 Key5770010
Report Number1287163-2016-50498
Device Sequence Number16305237
Product Code DZE
UDI-Device Identifier00614950005468
UDI-Public00614950005468
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K954513
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) 06/20/2016
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 Expiration Date04/30/2019
Device Model Number404010
Device Catalogue Number404010
Device Lot Number14050092
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2016
Initial Report FDA Received Date07/05/2016
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 Age52 YR
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