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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 203711
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Fistula (1862); Failure of Implant (1924)
Date of Event 03/28/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evidence was found with the implant after evaluation.Customer reported fistula, mobility and inadequate bone quality/bone quantity.
 
Event or Problem Description
Mobility, fistula and inadequate bone quality/bone quantity were reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation before prosthetic restoration.Primary stability was achieved.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 street
brockton MA 02301
MDR Report Key12567717
Report Number1287163-2021-52837
Device Sequence Number11829786
Product Code DZE
UDI-Device Identifier00614950004645
UDI-Public00614950004645
Combination Product (Y/N)N
Initial Reporter CountryLE
PMA/510(K) Number
K102981
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
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) 09/23/2021
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 Number203711
Device Catalogue Number203711
Device Lot Number16080034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date10/04/2021
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 Age51 YR
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