MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE IMPLANT; DENTAL IMPLANT

Catalog Number	655006
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Failure of Implant (1924); Sinus Perforation (2277)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the complaint, the implant passed through the sinus.

• Brand Name: INTERACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7711861
• Report Number: 3001617766-2018-00171
• Device Sequence Number: 2580330
• Product Code: DZE
• UDI-Device Identifier: 10841307100492
• UDI-Public: 10841307100492
• Combination Product (Y/N): N
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: Health Professional
• Device Expiration Date: 04/24/2023
• Device Catalogue Number: 655006
• Device Lot Number: 112653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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
• Patient Age: 51 YR