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

Catalog Number 825210

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Per complaint (b)(4), a dental implant stripped the hex tool during the implant's placement.Both were damaged.The implant was not used.

• 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
• Manufacturer Contact: monica roche ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7920584
• MDR Text Key: 122166651
• Report Number: 3001617766-2018-00242
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101437
• UDI-Public: 10841307101437
• 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,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/28/2018

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: 02/15/2022
• Device Catalogue Number: 825210
• Device Lot Number: 90376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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 Age: 73 YR