MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT

Catalog Number	877010
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight, event date, implant and explant dates were not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss of implant to integrate.

• Brand Name: LEGACY 4 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: 11574151
• Report Number: 3001617766-2021-01837
• Device Sequence Number: 17049346
• Product Code: DZE
• UDI-Device Identifier: 10841307103158
• UDI-Public: 10841307103158
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 12/27/2020
• Device Catalogue Number: 877010
• Device Lot Number: 72403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/26/2021
• 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: 78 YR