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

Catalog Number	336-2757
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 the distributor contacted osteomed to state that he needs to report a complaint.On (b)(6) 2019, the distributor notified osteomed the there was a broken plate.However, no details of the broken plate was provided.On (b)(6) 2019, the distributor notified osteomed that the broken plate was an explant.We are currently awaiting the full details of this case.
Additional Manufacturer Narrative
The returned 2.7mm, 1st mtp fusion plate right, 10°, p/n 336-2757, was determined by the surgeon to have broken post-op because the joint had not fused.The surgeon properly used all seven screw holes and added a trans-joint cannulated screw per the stg.There was no lot number provided; therefore, no review of the dhr was possible.A two-year review did not identify any capas or ncrs related to this implant.This is the first complaint for this issue, "broken plate, post-op, joint did not fuse", discovered in a two-year review of the complaint database.This plate is a part of the extremilock foot plating system (e-fps).The fmea covers the risk of plate breaking post-op.The predicted severity rating is 3.Per procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).Depending on the potential cause, the final predicted risk level is either "low" or "medium".The e-fps instructions for use (ifu) states this plate is not intended to endure excessive abnormal functional stresses.The ifu also states the plate is intended for temporary fixation only until osteogenesis occurs.It also warns that post-operative instructions should be given to the patient by the surgeon, including the potential for secondary injuries to a surgical site if the patient is non-compliant.Patients should be instructed to closely follow the post-operative instructions.This issue will be monitored through routine trending.

• Brand Name: EXTREMILOCK FOOT PLATING SYSTEM
• Common Device Name: 2.7MM - 1ST MTP FUSION PLATE RIGHT - 10°
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 9100339
• Report Number: 2027754-2019-00012
• Device Sequence Number: 13844181
• Product Code: HRS
• UDI-Device Identifier: 00845694041829
• UDI-Public: 00845694041829
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 336-2757
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention