MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT

Catalog Number 854713

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Nerve Damage (1979)

Event Date 07/31/2018

Event Type  Injury  

Event Description

Per complaint (b)(4), post-op the patient presented with partial numbness after the initial procedure.The implant was removed and replace with a shorter implant.Per the complaint, the implant was possibly impinging on the nerve canal.

• Brand Name: LEGACY 3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7900245
• MDR Text Key: 121434812
• Report Number: 3001617766-2018-00233
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102199
• UDI-Public: 10841307102199
• 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: 08/22/2018

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: Health Professional
• Device Expiration Date: 12/11/2022
• Device Catalogue Number: 854713
• Device Lot Number: 104869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR