MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY4¿ 3.2MMD X 11.5MML X 3.0MMD PLATFORM; DENTAL IMPLANT

Model Number 873211

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); No Code Available (3191)

Event Date 01/25/2018

Event Type  Injury  

Event Description

Per complaint number (b)(4), while placing implants buccal plate was fractured.Implants were removed and bone graft was placed.Qa investigation of returned implant determined that implant met all specifications and the event was likely due to an error in surgical procedure.

• Brand Name: LEGACY4¿ 3.2MMD X 11.5MML X 3.0MMD PLATFORM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7364520
• MDR Text Key: 103265339
• Report Number: 3001617766-2018-00052
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102809
• UDI-Public: 10841307102809
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/22/2018

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?: No
• Device Operator: Dentist
• Device Expiration Date: 06/21/2021
• Device Model Number: 873211
• Device Catalogue Number: 873211
• Device Lot Number: 80149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR