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

Model Number	09231322
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be an post-placement/pre-load implant failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors and/or the lack of osseointegration.The loss of integration or the non-integration of an endosseous dental implant is a known inherent risk of the procedure as described in this product's instructions for use.Physical analysis was not performed.
Event or Problem Description
Bone quality at the time of implant failure was type ii.Primary stability was achieved and osseointegration was not.1-5 years after restoration.Mobility was reported.Patient is a smoker.Poor oral hygiene.

• 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: 5528756
• Report Number: 1287163-2016-50417
• Device Sequence Number: 10949758
• Product Code: DZE
• UDI-Device Identifier: 00614950002535
• UDI-Public: 00614950002535
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K954513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/29/2016

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 Expiration Date: 12/30/2014
• Device Model Number: 09231322
• Device Catalogue Number: 09231322
• Device Lot Number: 10010058M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2016
• Initial Report FDA Received Date: 03/28/2016
• 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