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

Catalog Number HT3.0

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651); Vascular Dissection (3160)

Event Date 08/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient's identifier was not provided.When the requested information becomes available, supplementary report will be submitted.Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Pma/510(k) - not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).

Event Description

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

• 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: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10716873
• MDR Text Key: 212449852
• Report Number: 3001617766-2020-07443
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119654
• UDI-Public: 10841307119654
• 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 faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/21/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT3.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2020
• Initial Date FDA Received: 10/22/2020
• 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 Weight: 77