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

Catalog Number HT1.25

Device Problem Loss of Osseointegration (2408)

Patient Problems Granuloma (1876); Failure of Implant (1924)

Event Date 02/19/2022

Event Type  Injury  

Manufacturer Narrative

Lot information is unknown.If additional 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, product fracture was observed.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: HEX 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: 13685244
• MDR Text Key: 286735334
• Report Number: 3001617766-2022-01112
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119609
• UDI-Public: 10841307119609
• 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
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 67 KG