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

Catalog Number 6035-09PT

Device Problem Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Per complaint (b)(4), the lobes on scan body of scan adapter do not match up to what is in the software once it is scanned.

• Brand Name: REPLANT 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: 7787904
• MDR Text Key: 117432861
• Report Number: 3001617766-2018-00194
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123934
• UDI-Public: 10841307123934
• 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: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: 6035-09PT
• Device Lot Number: 104539
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• 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