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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 404713
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/28/2017
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
Asymptomatic, asymptomatic and bone loss were reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was performed at the time of 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 Key6888438
Report Number1287163-2017-00379
Device Sequence Number496481
Product Code DZE
UDI-Device Identifier00614950005536
UDI-Public00614950005536
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K954513
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/07/2017
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 Number404713
Device Catalogue Number404713
Device Lot Number16020056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/07/2017
Initial Report FDA Received Date09/22/2017
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 Age63 YR
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