MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT CLOSED-TRAY TRANSFER; DENTAL IMPLANT

Catalog Number 8530-05

Device Problem Loss of Osseointegration (2408)

Patient Problems Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.

Event Description

Per complaint (b)(4), after clinical procedure, patient experienced loss of implant to osseointegrate.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.

• Brand Name: LEGACY IMPLANT CLOSED-TRAY TRANSFER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 14220464
• MDR Text Key: 290175075
• Report Number: 3001617766-2021-06764
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121442
• UDI-Public: 10841307121442
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: 8530-05
• Device Lot Number: 89984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female