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

Model Number 204708

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The reported event has been determined to be a post-placement/pre-load failure.This implant loss suggests that the source of the problem was likely to stem from the lack of osseointegration.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.

Event Description

Inadequate bone quality/bone quantity, bleeding and pain were reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.Patient has diabetes.

• Brand Name: INTERNAL HEX IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton, ma
• Manufacturer (Section G): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton, ma
• Manufacturer Contact: doreen price ; 1034 pearl street; brockton, ma ; 4413100781
• MDR Report Key: 10301201
• MDR Text Key: 199648547
• Report Number: 1287163-2020-52477
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00614950004737
• UDI-Public: 00614950004737
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K102981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 204708
• Device Catalogue Number: 204708
• Device Lot Number: 17110025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR