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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 204713
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from procedural errors.Correct use and procedural instructions are described in this product's instructions for use.
 
Event or Problem Description
Mobility was reported.Bone quality at the time of implant failure was type ii.
 
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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 Key8163832
Report Number1287163-2018-00539
Device Sequence Number2791774
Product Code DZE
UDI-Device Identifier00614950004768
UDI-Public00614950004768
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K102981
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/30/2018
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 Number204713
Device Catalogue Number204713
Device Lot Number18070127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/30/2018
Initial Report FDA Received Date12/14/2018
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 Age61 YR
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