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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 205111
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 09/12/2018
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
Pain and inadequate bone quality/bone quantity were reported.Bone quality at the time of implant failure was type ii.Time of loss in relation to the implantation was 1 to 5 years after prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.
 
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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 Key7919564
Report Number1287163-2018-00509
Device Sequence Number11099533
Product Code DZE
UDI-Device Identifier00614950004812
UDI-Public00614950004812
Combination Product (Y/N)N
Initial Reporter StateFL
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) 09/25/2018
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 Number205111
Device Catalogue Number205111
Device Lot Number15060019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/25/2018
Initial Report FDA Received Date09/28/2018
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 Age32 YR
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