MAUDE Adverse Event Report: IMPLANT DIRECT LLC LOCATOR ABUTMENT LEGACY

Model Number	8035-92-L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While torquing locator abutment with 30 ncm torque wrench, the thread portion broke off inside the implant.The implant had to be removed and replaced, as a result.

• Brand Name: LOCATOR ABUTMENT LEGACY
• Common Device Name: ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 6939153
• Report Number: 3001617766-2017-00010
• Device Sequence Number: 1313032
• Product Code: NHA
• UDI-Device Identifier: 10841307111108
• UDI-Public: 10841307111108
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: D246125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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?: Yes
• Operator of Device: Dentist
• Device Model Number: 8035-92-L
• Device Catalogue Number: 8035-92-L
• Device Lot Number: I1ZBQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR