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

Catalog Number 6534-09PT

Device Problem Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

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 Description

Per complaint (b)(4), the peek part of the multi-use scan adaptor was loose on the titanium base.

Event Description

Per complaint (b)(4), the peek part of the multi-use scan adaptor was loose on the titanium base.

• Brand Name: INTERACTIVE PRECISION IO SCAN ADAPTER
• Type of Device: SCAN ADAPTOR
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8031219
• MDR Text Key: 126087970
• Report Number: 3001617766-2018-00280
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123477
• UDI-Public: 10841307123477
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: 872.3980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

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
• Device Operator: 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: 08/31/2018
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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