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

Catalog Number HD2.5

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2021

Event Type  Injury  

Event Description

Per complaint (b)(4), during clinical procedure, broken or fractured component was observed.

Manufacturer Narrative

Other relevant history, including preexisting medical conditions were not provided.If the requested information becomes available, a supplementary report will be submitted.Implant date is not applicable since the product was never placed.Explant date is unknown.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.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.

• Brand Name: HEX DRILL
• 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: 13116685
• MDR Text Key: 283084268
• Report Number: 3001617766-2021-07558
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119579
• UDI-Public: 10841307119579
• 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: 03/02/2022

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: HD2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 64 KG