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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INTERNAL HEX IMPLANT; DENTAL IMPLANT
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ACE SURGICAL SUPPLY COMPANY INTERNAL HEX IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 204113
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/12/2020
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
Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.
 
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Brand Name
INTERNAL HEX IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl stree
brockton MA 02301
MDR Report Key10806314
Report Number1287163-2020-52507
Device Sequence Number3569480
Product Code DZE
UDI-Device Identifier00614950004713
UDI-Public00614950004713
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K102981
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/03/2020
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 Number204113
Device Catalogue Number204113
Device Lot Number17060067
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2020
Initial Report FDA Received Date11/08/2020
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 Age47 YR
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