MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK ANKLE PLATING SYSTEM; 9H FIBULA FRACTURE PLATE, RIGHT

Catalog Number 336-5209

Device Problems Bent (1059); Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

On 03/12/2018, osteomed was notified of an incident concerning one of our implant devices.Per the distributor, the plate was implanted in (b)(6) 2017.However, they recently identified that the plate was bent and needed to be explanted.

Manufacturer Narrative

The exact root cause of why the plate, a 9 hole ankle plate, fibula fracture, right, p/n: 336-5209, bent four months post-implantation could not be determined.There are multiple possibilities.Some include allowing patient to bear weight prematurely, thus forcing the plate to experience excessive loads; excessively bending the plate prior to implantation; a poor plate design or material; or that the patient experienced an unreported secondary trauma to the same ankle.There was no lot number provided.Therefore, a review of the device history record (dhr) could not be performed.This plate design was initially released in march of 2014.The review of capas and ncrs since launch did not identify any investigations for this device.The review of complaints shows that this is the first complaint ever received for this device.The risk of a non-union with a related bent plate is covered in the extremilock ankle plating system (e-aps) risk document, and has an overall risk level schore of "medium".The e-aps ifu warns the user of the possible root causes such as use of undersized implants in areas of high functional stress, excessive bending of the plate pre-implantation, and expecting the plate system to endure excessive abnormal functional stresses.The ifu also alerts the user that the e-aps is intended for temporary fixation only until osteogenesis occur, and that the surgeon should provide post-operative instructions to the patient, including alerting the patient of the potential for secondary injuries to a surgical site if the patient is non-compliant.This issue will be monitored through routine trending.

• Brand Name: EXTREMILOCK ANKLE PLATING SYSTEM
• Type of Device: 9H FIBULA FRACTURE PLATE, RIGHT
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7388965
• MDR Text Key: 104263784
• Report Number: 2027754-2018-00009
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K133691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 336-5209
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention