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

Catalog Number	HT1.25S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's information, event date, other relevant history, including preexisting medical conditions, implant date and explant date were not provided.When the requested information becomes available, a 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 or Problem Description
Per complaint (b)(4), product fractured is experienced.
Additional Manufacturer Narrative
Follow up is being submitted to report that no patient was involved.Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type, h6 for no patient was involved.

• Brand Name: HEX TOOL SHORT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 10716874
• Report Number: 3001617766-2020-07438
• Device Sequence Number: 11591244
• Product Code: NDP
• UDI-Device Identifier: 10841307119678
• UDI-Public: 10841307119678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: HT1.25S
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention