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

Model Number	944812
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The abutment screw broke and caused the implant to fail.Implant was removed, requiring medical intervention.This is a reportable serious injury.

• Brand Name: SWISS ACTIVE 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: 7497234
• Report Number: 3001617766-2018-00099
• Device Sequence Number: 1417434
• Product Code: DZE
• UDI-Device Identifier: 10841307106739
• UDI-Public: 10841307106739
• Combination Product (Y/N): N
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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?: Yes
• Operator of Device: Dentist
• Device Model Number: 944812
• Device Catalogue Number: 944812
• Device Lot Number: 100075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: 54 YR