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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 Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 06/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from no osseointegration.Additionally, other factors that may have contributed to the implant failure includes bone condition, patient oral hygiene, overall health or behavior.Proper intended use of the implant is described in its instructions for use.Physical analysis cannot be performed.
 
Event or Problem Description
Pain and mobility were reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was up to 1 year after prosthetic restoration.Osseointegration was not 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
MDR Report Key9995489
Report Number1287163-2020-52398
Device Sequence Number19751913
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 Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/01/2020
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 Health Professional
Device Model Number404010
Device Catalogue Number404010
Device Lot Number18040031
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/25/2020
Initial Report FDA Received Date04/24/2020
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 Age53 YR
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