MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE HEALING COLLAR

Catalog Number	6530-13
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
As per complaint (b)(4), during a clinical procedure it was observed that a dental implant healing collar was not "seating" well and there was a gap between the healing collar head and the dental implant.

• Brand Name: INTERACTIVE HEALING COLLAR
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9597962
• Report Number: 3001617766-2020-00565
• Device Sequence Number: 3461227
• Product Code: NHA
• UDI-Device Identifier: 10841307109846
• UDI-Public: 10841307109846
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2024
• Device Catalogue Number: 6530-13
• Device Lot Number: 134599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention