MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 2 IMPLANT; DENTAL IMPLANT

Model Number	825713U
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017.Report late due to asr to individual reporting transition.
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted for correction.Updated section b4 for report submission date.Updated g1-g2 for follow-up report submitter and g7 for report type and follow-up number.Updated h2 for follow-up type.Updated d4 for catalog # and unique identifier (udi) #.Updated d4 for lot # to include ni for no information available.Section d4 for expiration date and h4 for device manufacture date no information available.

• Brand Name: SIMPLY LEGACY 2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thoudsand oaks CA 91362
• MDR Report Key: 8943267
• Report Number: 3001617766-2019-00641
• Device Sequence Number: 3079589
• Product Code: DZE
• UDI-Device Identifier: 10841307107576
• UDI-Public: 10841307107576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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 Model Number: 825713U
• Device Catalogue Number: 827013U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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: 52 YR