MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY¿3 IMPLANT; DENTAL IMPLANT

Catalog Number	857013
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Nerve Damage (1979); No Code Available (3191)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the complaint, during post operative appointment, patient present with parasthesia of lower left lip and chin 14 days after placement.The implant was removed.The doctor plans to observe for recovery and to replace in 3 months.Implant #19 in position intimate with superior of ian canal.Patient suffered nerve damage.
Additional Manufacturer Narrative
Device not returned to manufacturer.

• Brand Name: LEGACY¿3 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: 7608150
• Report Number: 3001617766-2018-00148
• Device Sequence Number: 16550247
• Product Code: DZE
• UDI-Device Identifier: 10841307102373
• UDI-Public: 10841307102373
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: Dentist
• Device Expiration Date: 02/08/2023
• Device Catalogue Number: 857013
• Device Lot Number: 109022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/16/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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: 61 YR