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

Catalog Number 6050-09PT

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Per internal complaint (b)(4), the flat scan of the scan adapter was found not aligned to the tri-lobe.

• Brand Name: PRECISION IO SCAN ADAPTER
• Type of Device: SCAN ADAPTER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7791700
• MDR Text Key: 117432935
• Report Number: 3001617766-2018-00197
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123958
• UDI-Public: 10841307123958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 872.398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/16/2018

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: No Information
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: 6050-09PT
• Device Lot Number: 104511
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1