MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISSPLANT OVERDENTURE ABUTMENT1MM COLLAR; DENTAL IMPLANT

Model Number	9037-61
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint# (b)(4), complainant reported broken screw and fractured implant.

• Brand Name: SWISSPLANT OVERDENTURE ABUTMENT1MM COLLAR
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7291104
• Report Number: 3001617766-2018-00029
• Device Sequence Number: 135838
• Product Code: DZE
• UDI-Device Identifier: 10841307116264
• UDI-Public: 10841307116264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081396
• 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): 02/22/2018

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: 9037-61
• Device Catalogue Number: 9037-61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 02/22/2018
• 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: 81 YR