MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 5MM HEALING COLLAR; DENTAL IMPLANT ABUTMENT

Model Number 8045-15

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2017

Event Type  malfunction  

Event Description

Per (b)(4), (b)(4) distributor reported finding an extraneous black particle on the healing collar inside a sealed vial.The product was not distributed to customers but the issue was noticed upon receipt inspection and returned to implant direct for qa inspection.Qa performed a visual inspection substantiating the customers claim.There was a black particle resting on the largest diameter of the healing collar; however, investigation is not yet complete.

• Brand Name: LEGACY 5MM HEALING COLLAR
• Type of Device: DENTAL IMPLANT ABUTMENT
• 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: 7329223
• MDR Text Key: 102333144
• Report Number: 3001617766-2018-00041
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111337
• UDI-Public: 10841307111337
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 11/29/2021
• Device Model Number: 8045-15
• Device Catalogue Number: 8045-15
• Device Lot Number: 86354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1