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

Model Number	204713
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/25/2015
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
Mobility was reported at the time of implant failure.No primary stability and no osseointegration was achieved.Augmentation procedure was not performed at the time of surgery.Bone quality at the time of implant failure was type iii.Patient was a smoker.

• 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 Key: 5358345
• Report Number: 1287163-2016-50275
• Device Sequence Number: 691684
• Product Code: DZE
• UDI-Device Identifier: 00614950004768
• UDI-Public: 00614950004768
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K102981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Report Date (Section B): 01/04/2016

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 Model Number: 204713
• Device Catalogue Number: 204713
• Device Lot Number: 14030038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2016
• 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