MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM; PLATE, FIXATION, BONE

Model Number 241.361

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Add'l patient identifier: (b)(6).Implanted several years ago; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient underwent a hardware removal due to pain on (b)(6) 2018.The hardware removed were one (1) malleolar screw, five (5) cortex screws, two (2) cancellous screw and one (1) tubular plate.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.This report is for one (1) lcp one third tubular plate.This is report 4 of 4 for complaint (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8195383
• MDR Text Key: 131374338
• Report Number: 2939274-2018-55567
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982166876
• UDI-Public: (01)10886982166876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.361
• Device Catalogue Number: 241.361
• Device Lot Number: 7645609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 68