MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE 3.2MMDX10MML SBM 3.0MMD PLATFORM; DENTAL IMPLANT

Model Number	6035-95
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reports that a screw thread of the replant locator® abutment 3.5dx3l fractured during a clinical procedure resulting in a loss of the implant, requiring medical intervention.This incident is a reportable serious injury.This is the only complaint for this part number indicating there is no upward trend for this issue.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.(b)(4).Device received is different from that which was submitted on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.

• Brand Name: INTERACTIVE 3.2MMDX10MML SBM 3.0MMD PLATFORM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7435156
• Report Number: 3001617766-2018-00063
• Device Sequence Number: 196202
• Product Code: NHA
• UDI-Device Identifier: 10841307113188
• UDI-Public: 10841307113188
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Model Number: 6035-95
• Device Catalogue Number: 856706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1