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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 403708
Health Effect - Clinical Code Inflammation (1932)
Date of Event 06/03/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be an 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.The loss of integration or the non-integration of an endosseous dental implant is a known inherent risk of the procedure as described in this product's instructions for use.Physical analysis was not performed.
 
Event or Problem Description
Mobility was reported.Primary stability and osseointegration was achieved.Periimplantitis was noticed during the implant surgery.
 
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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 Key5471088
Report Number1287163-2016-50290
Device Sequence Number10998561
Product Code DZE
UDI-Device Identifier00614950005406
UDI-Public00614950005406
Combination Product (Y/N)N
Initial Reporter CountryPO
PMA/510(K) Number
K954513
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/08/2016
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 Number403708
Device Catalogue Number403708
Device Lot Number11100027
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2016
Initial Report FDA Received Date03/01/2016
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
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