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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY XHEX IMPLANT; DENTAL IMPLANT
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ACE SURGICAL SUPPLY COMPANY XHEX IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 09231326
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from mobility.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
Mobility was reported.Time of loss in relation to the implantation was 1 to 5 years after prosthetic restoration.
 
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Brand Name
XHEX IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ACE SURGICAL SUPPLY COMPANY
1034 pearl street
brockton MA 02301
MDR Report Key10842612
Report Number1287163-2020-52539
Device Sequence Number4177858
Product Code DZE
UDI-Device Identifier00614950002580
UDI-Public00614950002580
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K954513
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2019
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) 11/11/2020
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 Number09231326
Device Catalogue Number09231326
Device Lot Number07020088M
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2020
Initial Report FDA Received Date11/16/2020
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;
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