MAUDE Adverse Event Report: ACUMED LLC POLARUS® 3 STANDARD PLATE 4-HOLE L; PLATE, FIXATION, BONE

Model Number 7001-0104L

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  malfunction  

Event Description

Following implantation of a polarus 3 standard plate, the patient complained about an adverse reaction to the plate.To date, the implant has not been removed.

• Brand Name: POLARUS® 3 STANDARD PLATE 4-HOLE L
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9818070
• MDR Text Key: 187743623
• Report Number: 3025141-2020-00045
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7001-0104L
• Device Catalogue Number: 7001-0104L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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