MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; DENTAL IMPLANT

Catalog Number	HT2.5LG
Medical Device Problem Codes	Separation Failure (2547); Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight, event date and explant date were not provided.When the requested information becomes available, a supplementary report will be submitted.Lot information is unknown.If additional 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.Pma/510(k) - not applicable.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, components could not be separated.

• Brand Name: SIMPLYLEGACY DRIVER
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 11321430
• Report Number: 3001617766-2021-01094
• Device Sequence Number: 3444313
• Product Code: NDP
• UDI-Device Identifier: 10841307119852
• UDI-Public: 10841307119852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• 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): 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HT2.5LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement 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
• Patient Age: 71 YR
• Patient Weight: 57