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

Catalog Number	863210
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during post operative check, patient experienced loss or failure of implant to integrate.
Event or Problem Description
Reviewed attached customer feedback form.Contraindications relevant to failure: patient is over 60 years old.Part: 863210.Revision: a.Visual: implant received is slightly damaged.Specification should be: length:.404 ±.003, specification as found:.4062, diameter:.1250 /.1265, specification as found:.1250.Comments: this implant was damaged around the collar area at the time it was removed from the patients mouth.Performed a visual and dimensional inspection on the product received and it meets our specifications.Date of inspection: 09/26/2019.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• 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: 9081617
• Report Number: 3001617766-2019-03737
• Device Sequence Number: 14153753
• Product Code: DZE
• UDI-Device Identifier: 10841307102397
• UDI-Public: 10841307102397
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/04/2019

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: 04/06/2024
• Device Catalogue Number: 863210
• Device Lot Number: 137212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: 63 YR