MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DLC STEP DRILL 2.3/2.0MM (6-16MML); DENTAL IMPLANT

Catalog Number SD2.3C

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier, other relevant history, including preexisting medical conditions, implant date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient age is unknown.Lot information unknown.If additional information becomes available a supplementary report will be submitted.Udi number is not applicable.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

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

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.

• Brand Name: DLC STEP DRILL 2.3/2.0MM (6-16MML)
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12365109
• MDR Text Key: 268052900
• Report Number: 3001617766-2021-05006
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• PMA/PMN Number: K200265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD2.3C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84