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

Model Number 08634

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Fracture in the threaded area of the abutment is typically caused by screw loosening followed by fatigue failure from repeated mastication cycles.Screws typically come loose due to either an inadequate application of torque at placement or lack of maintenance.Zest recommends most abutments be tightened to 30 ncm or the level indicated by the implant manufacturer.The final application of torque should always be completed by using a calibrated torque indicator and failure to do so can lead to screw loosening and eventual failure.Screw loosening can also be addressed by retightening abutments during routine maintenance appointments which can help reduce the likelihood of screw fracture.Clinician did not provide the following information: whether primary stability was achieved.Per ifu, patients should be instructed to maintain routine follow-up visits for hygiene and attachment function evaluation.Abutments must be re-tightened at follow-up visits to the torque specifications listed in the ifu.Follow-up visits are recommended at 6 month intervals.

Event Description

Customer indicated that the locator abutment fractured and a portion of the abutment broke off inside the implant.If the screws are unable to be retrieved.Then the implant will be non-restorable.Surgical intervention may be required to remove the implant.

Manufacturer Narrative

Fracture in the threaded area of the abutment is typically caused by screw loosening followed by fatigue failure from repeated mastication cycles.Screws typically come loose due to either an inadequate application of torque at placement or lack of maintenance.Zest recommends most abutments be tightened to 30 ncm or the level indicated by the implant manufacturer.The final application of torque should always be completed by using a calibrated torque indicator and failure to do so can lead to screw loosening and eventual failure.Screw loosening can also be addressed by retightening abutments during routine maintenance appointments which can help reduce the likelihood of screw fracture.Clinician did not provide the following information: whether primary stability was achieved.Per ifu, patients should be instructed to maintain routine follow-up visits for hygiene and attachment function evaluation.Abutments must be re-tightened at follow-up visits to the torque specifications listed in the ifu.Follow-up visits are recommended at 6 month intervals.Final evaluation of the device was performed.Conclusion: failure to follow instructions; device fracture was technique related most likely due to overtorquing the abutment or failure to retighten the loose screw during routine maintenance.

Event Description

Customer indicated that the locator abutment fractured and a portion of the abutment broke off inside the implant.If the screws are unable to be retrieved.Then the implant will be non-restorable.Surgical intervention may be required to remove the implant.

• 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: 6596105
• MDR Text Key: 76126311
• Report Number: 2023950-2017-00160
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K9942157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 08634
• Device Catalogue Number: 08634
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2017
• 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): Required Intervention