MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT STRAIGHT ABUTMENT; DENTAL IMPLANT

Catalog Number 6050-21

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)

Event Date 08/15/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), during post operative check, patient experienced loss of implant to integrate due to bone loss.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: REPLANT STRAIGHT ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9129252
• MDR Text Key: 160346292
• Report Number: 3001617766-2019-04130
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307113683
• UDI-Public: 10841307113683
• Combination Product (y/n): N
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: 6050-21
• Device Lot Number: 74717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention