MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Catalog Number 833210

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), a driver tool broke inside a dental implant during initial placement.The broken piece was unable to be removed.The implant was removed and replaced within the same procedure.No adverse patient consequences were reported.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated report submission date and report device evaluation results.Updated device return date, follow-up report submitter, awareness date and report type and follow-up number.Updated follow-up type, device evaluation status and method, result and conclusion codes.

• Brand Name: LEGACY 2 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8597658
• MDR Text Key: 144704915
• Report Number: 3001617766-2019-00216
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101598
• UDI-Public: 10841307101598
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: 833210
• Device Lot Number: 131774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR