MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE STRT ABUT 5.7MMD 3.4X2MML; DENTAL IMPLANT

Model Number	6534-22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Dentist reports a fractured dental implant screw.

• Brand Name: INTERACTIVE STRT ABUT 5.7MMD 3.4X2MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7453135
• Report Number: 3001617766-2018-00074
• Device Sequence Number: 127894
• Product Code: DZE
• UDI-Device Identifier: 10841307110163
• UDI-Public: 10841307110163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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
• Operator of Device: Dentist
• Device Model Number: 6534-22
• Device Catalogue Number: 6534-22
• Device Lot Number: 87348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 59 YR