MAUDE Adverse Event Report: ACUMED LLC LEFT 20 HOLE LOCKING LATERAL PLATE; PLATE, FIXATION, BONE

Model Number PL-LEL20L

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 04/03/2019

Event Type  malfunction  

Event Description

The implanted left 20 hole locking lateral elbow plate "ruptured".

• Brand Name: LEFT 20 HOLE LOCKING LATERAL PLATE
• 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 ; 8886279957
• MDR Report Key: 8707753
• MDR Text Key: 148602002
• Report Number: 3025141-2019-00313
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102998
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL-LEL20L
• Device Catalogue Number: PL-LEL20L
• Device Lot Number: 279776
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2012
• 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
• Patient Age: 37 YR