MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE PRECISION IO SCAN ADAPTER; SCAN ADAPTOR

Catalog Number	6534-09PT
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection confirmed product is out of specification.The potential cause is due to incorrect manufacturing.According to the risk management report, the severity of harm is serious.Complaint will be escalated for further investigation.
Event or Problem Description
Per complaint (b)(4), during the removal of the peek-titanium scan adapter for the dental implant, the peek part was loose on the titanium base.The scan adaptor was compromised and a new appointment was scheduled for the patient.There was no patient involvement.

• Brand Name: INTERACTIVE PRECISION IO SCAN ADAPTER
• Common Device Name: SCAN ADAPTOR
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8001429
• Report Number: 3001617766-2018-00277
• Device Sequence Number: 1301910
• Product Code: NDP
• UDI-Device Identifier: 10841307123477
• UDI-Public: 10841307123477
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: 872.3980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 11/08/2022
• Device Catalogue Number: 6534-09PT
• Device Lot Number: 104479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1