MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTUR IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Catalog Number 07460, 07465

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

Clinician decided to change the abutments one month after implant placement (before osseointegration of the implants had occurred) and inadvertently extracted the implants.Expiration date: (b)(4)-01/31/2019, (b)(4)- 02/28/2019.

Manufacturer Narrative

One month after implant placement (prior to the osseointegration of the implant), the clinician decided to use a different abutment (change cuff height).They proceeded to remove the torqued abutments and inadvertently extracted the non-integrated implants.So, the pt will require additional surgical intervention to replace the implants that were taken out.As intended, torquing an abutment permanently secures it onto the implant.Therefore, in order to remove the torqued abutment, the clinician would have to apply a reverse-torque, which would also extract the implant if it has not yet been integrated into the bone.The (b)(6) user documentation ((b)(4)) includes information on pre-surgical treatment planning.The clinician is instructed to measure the gingiva depth at each implant depth prior to implant placement to properly select the abutment cuff height.Based on the above, it was concluded that this event occurred as a result of the clinician's misuse of the device (user error).The lot history records of the implants were reviewed and no discrepancies or issues of non-conformance were noted.No further action is required.

• Brand Name: LOCATOR OVERDENTUR IMPLANT SYSTEM (LODI)
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2061 wineridge pl.; escondido CA 92029
• Manufacturer Contact: annie wright, mgr ; 2061 wineridge place; escondido, CA 92029 ; 7607437744
• MDR Report Key: 4181378
• MDR Text Key: 5156285
• Report Number: 2023950-2014-00013
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/01/2014

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 Catalogue Number: 07460, 07465
• Device Lot Number: I0MXJ, I0NAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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