MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC IMPLANT REMOVAL TOOL; DENTAL IMPLANT

Catalog Number IXT

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Implant date and explant date are not applicable since the product was never placed and not removed.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), during clinical procedure, product broken or fractured component.

Manufacturer Narrative

Follow-up submitted for additional information.

• Brand Name: IMPLANT REMOVAL TOOL
• 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: 12567441
• MDR Text Key: 274428056
• Report Number: 3001617766-2021-05818
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119418
• UDI-Public: 10841307119418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IXT
• Device Lot Number: 183394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/16/2021; 12/01/2021
• Supplement Dates FDA Received: 11/23/2021; 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 79 KG