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

Catalog Number	605011U
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during post operative check, patient experienced loss of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated for device return date, for follow-up report submitter, for awareness date and for report type and follow-up number.Updated for follow-up type, for device evaluation status and method, result and conclusion codes.

• Brand Name: SIMPLY REPLANT 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: 9129264
• Report Number: 3001617766-2019-04135
• Device Sequence Number: 3122898
• Product Code: DZE
• UDI-Device Identifier: 10841307108351
• UDI-Public: 10841307108351
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/29/2019

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 Expiration Date: 01/04/2023
• Device Catalogue Number: 605011U
• Device Lot Number: 107037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: 65 YR