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 (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: 7281364
• Report Number: 3001617766-2018-00007
• Device Sequence Number: 13765568
• Product Code: DZE
• UDI-Device Identifier: 10841307102595
• UDI-Public: 10841307102595
• Combination Product (Y/N): N
• 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