MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM; 2.7MM X 30MM DOUBLE-LEAD LOCKING SCREW, T8

Catalog Number 338-2730

Device Problem Metal Shedding Debris (1804)

Patient Problem Toxicity (2333)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

Neither the plate (2.7mm - 5 hole straight plate, p/n 336-2700), screws (2.7mm locking screws, double lead, p/n's 338-2728 & 338-2730), nor any of the fragments of the reported debris, were returned to osteomed for examination.The complaint that there was debris suspected to be metallosis found near the implant could not be confirmed.Therefore, no root cause could be determined.Metallosis is the medical condition involving deposition and build-up of metal debris in the soft tissues of the body.Metallosis has been hypothesized to occur when metallic components in medical implants, generally joint replacements, grind against one another.The patient had no other metal implants in proximity to the plate (and screws) in question.The extremilock foot plating system ifu, p/n 030-1826, provides a warning not to allow implants of dissimilar metals to be used together in or near the implant site.None of the implants involved in this complaint were reported with their lot numbers, therefore, no review of the related dhrs were possible.A two-year review of capas did not identify any capa investigations for this device.Due to the nature of this complaint, and the information available, a review of the ncrs is not applicable.The review of the complaint history for this implant shows that this is the first complaint ever received for this device.This issue will be monitored through routine trending.

Event Description

On (b)(4) 2017, osteomed was notified of a case using extremilock foot in which the patient was suspected to have metallosis.No part numbers were provided at that time (b)(4).On (b)(4) 2017, we received notification of this device used within the case - p/n 338-2730.Per information from the distributor, this was observed during routine implant removal following healing of the fracture site.There were no other metal implants in proximity of the plate in question.The patient was not tested for metal sensitivity, and the patient had no symptoms.

• Brand Name: EXTREMILOCK FOOT PLATING SYSTEM
• Type of Device: 2.7MM X 30MM DOUBLE-LEAD LOCKING SCREW, T8
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer Contact: latoia phillips ; 3885 arapaho road; addison, TX 75001
• MDR Report Key: 6962130
• MDR Text Key: 89740869
• Report Number: 2027754-2017-00012
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K131445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 338-2730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• 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
• Patient Outcome(s): Required Intervention