MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT HEALING COLLAR; DENTAL IMPLANT

Catalog Number 6043-13

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.

• Brand Name: REPLANT HEALING COLLAR
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10934542
• MDR Text Key: 219149001
• Report Number: 3001617766-2020-08459
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307113348
• UDI-Public: 10841307113348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061319
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6043-13
• Device Lot Number: 159351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2020
• 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: 55 YR
• Patient Weight: 72