MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY XHEX IMPLANT; DENTAL IMPLANT

Model Number	09231326
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from loss of osseointegration and 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, infection and bleeding were reported.Time of loss in relation to the implantation was 1 to 5 years after prosthetic restoration.Primary stability and osseointegration was achieved.Augmentation procedure was not performed at the time of surgery.

• Brand Name: XHEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• MDR Report Key: 11581166
• Report Number: 1287163-2021-52762
• Device Sequence Number: 4781908
• Product Code: DZE
• UDI-Device Identifier: 00614950002580
• UDI-Public: 00614950002580
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• 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): 03/17/2021

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 Number: 09231326
• Device Catalogue Number: 09231326
• Device Lot Number: 10120012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR