MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY4 IMPLANT; LEGACY¿4 IMPLANT

Model Number 885711

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 07/21/2017

Event Type  malfunction  

Event Description

Hex drill got stuck in the implant and would not come out.The doctor ended up having to remove the implant.

• Brand Name: LEGACY4 IMPLANT
• Type of Device: LEGACY¿4 IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: evan garner ; 3050 e hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 6842603
• MDR Text Key: 84838825
• Report Number: 3001617766-2017-00007
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/05/2017

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: Dentist
• Device Expiration Date: 08/21/2017
• Device Model Number: 885711
• Device Catalogue Number: 885711
• Device Lot Number: 68095
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/05/2017
• Date Device Manufactured: 08/27/2015
• 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): Other
• Patient Age: 39 YR