MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM; 2.7MM 1ST MTP FUSION PLATE RIGHT - 10

Catalog Number 336-2757

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

The physician implanted the 2.7mm - 1st mtp fusion plate right - 10 degrees into the pt on (b)(6) 2015.During the six (6) week follow up visit, it was revealed that the plate was broken.The plate was explanted on (b)(6) 2015.

Manufacturer Narrative

The review of the dhr for this lot did not identify any non-conformances.The review of internal trending did not identify any negative trends for this part.This review of this issue against the risk profile does not indicate that an update is required.The explanted device was returned to osteomed for eval.The plate thickness is the most critical dimension for plate strength.The thickness of the returned plate, measured as several locations, was found to be within spec.The plate was implanted without using a cannulated lag screw under the plate.The use of this cannulated screw is indicated by the extremilock surgical technique guide, and serves to provide compression across the 1st mtp joint.Also, there was no screw implanted in the plate hole where the break occurred.Omission of this screw increases the likelihood of plate failure when subjected to loading.Omission of these screws alone will not cause the plate to fail unless the plate is also subjected to excessive stress due to loading.The ifu for the extremilock foot plating system, implants are not intended to endure excessive abnormal functional stresses.

• Brand Name: EXTREMILOCK FOOT PLATING SYSTEM
• Type of Device: 2.7MM 1ST MTP FUSION PLATE RIGHT - 10
• Manufacturer (Section D): OSTEOMED; addison TX
• Manufacturer Contact: 3885 arapaho rd.; addison, TX 75001 ; 9726774743
• MDR Report Key: 4847712
• MDR Text Key: 5872561
• Report Number: 2027754-2015-00006
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 336-2757
• Device Lot Number: 1073897
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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
• Patient Age: 58 YR