MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT 4.7MMD X 13MML; DENTAL IMPLANT

Model Number	864713
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Mdr submission for hhe (b)(4) product complaint# (b)(4) reports patient presented with paresthesia of three weeks duration.Radiographs although hard to read could be interpreted as implants #29 and #31 impinging on mandibular nerve.Decision to back these two implants.Replaced #31 with 11.5 mml and #29 with 13mml.Allowing #29 implant site to heal four months before replacing fixture.No infection and osseointegration appeared to be proceeding well.
Additional Manufacturer Narrative
Follow-up report is being submitted as a response to an fda request.The original follow-up was submitted under mdr 3500a 3001617766-2018-00046.A follow-up is being submitted to correct follow-up submission report number.(b)(4).
Event or Problem Description
Per complaint (b)(4), a patient presented with paresthesia of three weeks duration.Radiographs although hard to read could be interpreted as implants #29 and #31 impinging on mandibular nerve.Decision to back these two implants.Replaced #31 with 11.5 mml and #29 with 13mml.Allowing #29 implant site to heal four months before replacing fixture.No infection and osseointegration appeared to be proceeding well.

• Brand Name: LEGACY 3 IMPLANT 4.7MMD X 13MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7281407
• Report Number: 3001617766-2018-00008
• Device Sequence Number: 1250795
• Product Code: DZE
• UDI-Device Identifier: 10841307102595
• UDI-Public: 10841307102595
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 10/09/2022
• Device Model Number: 864713
• Device Catalogue Number: 864713
• Device Lot Number: 101128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 01/07/2020
• 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: 62 YR