MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; DENTAL IMPLANT

Catalog Number HT2.0LG

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Customer will be contacted.

Event Description

As per complaint (b)(4) during a clinical procedure a dental accessory fractured and could not be separated.There was 1 patient involved in this event.

Manufacturer Narrative

Corrections made: b1 product problem, b2 should be blank, h1 malfunction, h5 should be no.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #, 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.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.Pma/510(k) number updated (b)(4).

• Brand Name: SIMPLYLEGACY DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10401690
• MDR Text Key: 202719835
• Report Number: 3001617766-2020-06119
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 05/07/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: HT2.0LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 09/08/2020
• Supplement Dates FDA Received: 08/13/2020; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR