MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. PRIMA; PRIMACONNEX TAPERED SD 3.5X10

Model Number 15413K

Device Problems Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported that the implant loss osseointegration when the patient tried to remove their denture.A request for additional information also provided that the clinician used to large of a locator abutment which contributed to the failure.Keystone dental inc.Provides labeling with all implants.Failure to osseointegrate and loss of osseointegration (implant mobility) is identified as an adverse reaction and identified in the list of warnings in all endosseous dental implant labeling.The specific cause for a particular complaint is often not readily identified as there are various factors that contribute to the risk of implant failure.These include patient factors such as prior oral infection, poor bone quality or quantity, systemic conditions such as diabetes and uncontrolled hypertension.Technique factors such as overheating of the implant site may cause necrosis of the bone, preventing growth (pelayo et al., 2008; turkyilmaz & al., 2008).Patient habits such as tobacco use (heitz-mayfield & huynh-ba, 2009), alcohol or drug abuse, poor oral hygiene, and bruxism (salvi & braegger, 2009) may also lead to implant failure.In addition, improper surgical technique can lead to implant failure and/or loss of supporting bone (salvi & braegger, 2009).

Event Description

Loss of osseointegration.

• Brand Name: PRIMA
• Type of Device: PRIMACONNEX TAPERED SD 3.5X10
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer Contact: ryan raymond ; 154 middlesex turnpike; burlington, MA 01803
• MDR Report Key: 15711602
• MDR Text Key: 302824368
• Report Number: 3005990499-2022-14396
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: 15413K
• Device Catalogue Number: 15413K
• Device Lot Number: 21439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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: 72 YR
• Patient Sex: Male