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

Catalog Number 8035-62

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 08/19/2022

Event Type  Injury  

Event Description

Per complaint (b)(4), during clinical procedure, fracture of bone was observed.

Manufacturer Narrative

Patient's weight is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: LEGACY OVERDENTURE ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443315
• MDR Report Key: 15456559
• MDR Text Key: 300252996
• Report Number: 3001617766-2022-04565
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111498
• UDI-Public: 10841307111498
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090234
• 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Catalogue Number: 8035-62
• Device Lot Number: 132197
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2019
• 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: 63 YR
• Patient Sex: Female