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

Catalog Number 8042P11

Device Problem Positioning Problem (3009)

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

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

No information available.Pending return of device for evaluation.

Event Description

Per complaint (b)(4), patient experienced lack of primary stability.

• Brand Name: LEGACYP IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 9966712
• MDR Text Key: 187849148
• Report Number: 3001617766-2020-03339
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/16/2020

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: 07/15/2023
• Device Catalogue Number: 8042P11
• Device Lot Number: 120021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2018
• 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: 37 YR