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

Catalog Number	827013U
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994)
Date of Event	01/25/2018
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) , during post operative check it was observed that patient experienced loss or failure of implant to integrate.

• Brand Name: SIMPLY LEGACY 2 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: 9025325
• Report Number: 3001617766-2019-03415
• Device Sequence Number: 11235588
• Product Code: DZE
• UDI-Device Identifier: 10841307107620
• UDI-Public: 10841307107620
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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 Catalogue Number: 827013U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 09/13/2019
• 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: 71 YR