MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYFIXED LEGACY SMART PACK; DENTAL IMPLANT ABUTMENT

Model Number	8045-64-15SK
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reports three out of six ordered legacy dentistry smart packs were received opened and missing parts with writing on label.This was identified before use.There was no patient involvement.There have been no other reported events for this part and lot number.

• Brand Name: SIMPLYFIXED LEGACY SMART PACK
• Common Device Name: DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7528192
• Report Number: 3001617766-2018-00122
• Device Sequence Number: 1176393
• Product Code: NHA
• UDI-Device Identifier: 10841307117841
• UDI-Public: 10841307117841
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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 Expiration Date: 11/19/2020
• Device Model Number: 8045-64-15SK
• Device Catalogue Number: 8045-64-15SK
• Device Lot Number: 71239
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1