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

Catalog Number	704210
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	03/24/2018
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), patient experienced failure of implant to integrate.

• Brand Name: REPLUS 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: 8938476
• Report Number: 3001617766-2019-00600
• Device Sequence Number: 19370928
• Product Code: DZE
• UDI-Device Identifier: 10841307104247
• UDI-Public: 10841307104247
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K073161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/27/2019

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: 704210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 08/28/2019
• 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: 55 YR