MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR IMPLANT ATTACHMENT SYSTEM; ENDOSSEOUS DENTAL IMPLANT ABUTMENT

Model Number 08758

Device Problems Break (1069); Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problem Difficulty Chewing (2670)

Event Date 10/13/2016

Event Type  Injury  

Event Description

Clinician indicated that surface of the locator abutment is damaged and abutment is loose after 4 years.The clinician also indicated that the event involved a serious injury to the patient.Patient has problems chewing and has stomach trouble.

Manufacturer Narrative

Final evaluation of the device was performed.Excessive wear/damage on the head (scoring) evidenced by scoring or gouges on the coronal surface of the abutment.No other material or geometric defect was observed.Probable cause: gouges or score marks on the coronal surface of the locator abutment is most likely caused by the patient biting the prosthesis into place.The gouges are a result of not having the denture housing and abutment properly aligned during insertion and using a bite force to achieve final seating of the prosthesis (denture housing) on to the locator abutment.When this occurs, the edge of the denture housing scrapes along the outer surface of the abutment causing gouges in the underlying titanium substrate thereby distorting the geometry of the locator abutment to the extent that it will no longer provide proper retention of the nylon male.One other possible cause would be a lack of hygiene where an accumulation of plaque in the nylon male would abrade the abutment each time it was removed and replaced resulting in the same wear pattern described above.Since the wear (gouges on the locator abutment) was most likely caused by forcing alignment of the denture housing and prosthesis on to the abutment through bite force or lack of hygiene, the root cause is attributed to improper technique or misuse.

Event Description

Clinician indicated that surface of the locator abutment is damaged and abutment is loose after 4 years.The clinician also indicated that the event involved a serious injury to the patient.Patient is suffering; patient has problems chewing and has stomach trouble.

• Brand Name: LOCATOR IMPLANT ATTACHMENT SYSTEM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: olivia kim ; 2875 loker avenue east; carlsbad, CA 92010 ; 7607437744
• MDR Report Key: 6521022
• MDR Text Key: 73665968
• Report Number: 2023950-2017-00121
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K9942157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 08758
• Device Catalogue Number: 08758
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2017
• 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): Other