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

Catalog Number	934112
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Failure of Implant (1924); Nerve Damage (1979)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient presented to the dentist.Their dental implant had to be removed because the patient said that the side the implant was on went numb.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated for analysis awareness date, and for report type and follow-up number.Updated for follow-up type, for device evaluation status, and for method, result and conclusion codes.

• Brand Name: SWISHTAPERED 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: 8380303
• Report Number: 3001617766-2019-00073
• Device Sequence Number: 2887732
• Product Code: DZE
• UDI-Device Identifier: 10841307106418
• UDI-Public: 10841307106418
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/25/2019

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: 08/13/2020
• Device Catalogue Number: 934112
• Device Lot Number: 66263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: 59 YR