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

Catalog Number	336-2777
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, osteomed was notified of an incident that occurred with our 2.7mm - 1st transfixation mtp fusion plate right - 10° (p/n 336-2777).Per the distributor, the plate was implanted on (b)(6) 2019, and was a revision procedure after a competitor plate (believed to be an anchorage plate) broke.During the patient's 6 week up check, now appears to show the revision plate is broken.
Additional Manufacturer Narrative
The 1st mtp/mpj plate, right, 10°, p/n 336-2777, was not returned, as it is still implanted in the patient.Two x-rays were supplied which clearly indicated the plate had broken into two distinct parts.The history of this patient was that this was the second plate to break (same location in the foot).The root cause for the plate breakage is a non-compliant patient.There was no lot number provided.Therefore, a review of the dhr for this lot was not possible.A two-year review did not identify any capas or ncrs related to this implant.This is the only complaint for this implant within the last two (2) years.This plate is a part of the extremilock foot plating system (e-fps).The e-fps risk document includes an assessment of this failure mode.This issue has a severity rating of 3, which corresponds to 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) lists as a contraindication, "patients exhibiting disorders which would cause the patient to ignore the physician's pre- and/or post-operative instructions and/or the limitations of internal rigid fixation implants".The ifu also warns that this implant is not intended to endure excessive abnormal functional stresses.It says the plate is intended for temporary fixation only until osteogenesis occurs.The ifu states, "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.
Additional Manufacturer Narrative
This is an updated to original investigation.The plate, a 1st mtp transfixation fusion plate (right, 10°) and seven screws were explanted and returned for evaluation.However, there was no lag screw returned.This plate is a part of the extremilock foot plating system.There are two suggested ways to fuse the 1st mtp joint of the foot per the surgical technique guide (stg) for the extremilock foot plating system (e-fps).Both techniques involve a plate over the joint, and a lag screw placed diagonally across the 1st mtp joint.Both techniques use the lag screw to "cross through the joint and into the plantar aspect of the opposing bone in the joint resisting plantar gapping through normal gait" per the stg.That means the lag screw holds the two bones of the joint in contact, and maintains this position even while the patient does some walking.The bones have to touch, and maintain this proximity, for new bone growth, "osteogenesis", to occur.The plate fixates the top of the joint, and the lag screw keeps the central surfaces of the two bones in contact.The pair of implants form a construct, which maximizes the opportunity for the patients' toe joint bones to fuse together.Without the lag screw, during walking, the bottom of the joint can separate, or open slightly.This interrupts or stops osteogenesis.Review of the x-ray provided shows the broken 1st mtp transfixation fusion plate (right, 10°), p/n 336-2777, and seven screws.However, there was no screw seen that crossed the joint.For the plate to break, there was some outside force.That force could come instantly from a single extreme force event (like a car wreck), or hundreds/thousands of smaller forceful events (like standing or walking), that weaken and eventually break the plate over time.It appears that the plate broke due to six-weeks of weight stress (standing) and flexing (walking) which was intensified due to the lack of joint fusion.The plate was designed for temporary fixation until osteogenesis occurs.It is known that the joint did not fuse.It is also known that the patient was severely obese.This meant that all standing and walking imposed excessive, abnormal, functional stress upon the plate.Since the joint did not fuse, all stresses upon the joint were translated through the plate over an extended period of time.The plate is not designed for long-term joint replacement, and eventually broke.The receipt of the explanted screws and plate revealed that the surgeon did not use a lag screw across the joint.Therefore, it is now known that the surgeon did not follow the transfixation plate technique as is outlined in the surgical technique guide for this procedure.The lack of the lag screw meant the joint experienced more movement than it would have with implantation of a lag screw.This constant opening and closing of the joint is known to slow, or prevent, bone fusion.Two other factors might have contributed to the lack of fusion.Those factors include a possible non-compliant patient (walking too early or too much) and other health related issues that could have limited osteogenesis (such as smoking or being overweight).

• Brand Name: EXTREMILOCK FOOT PLATING SYSTEM
• Common Device Name: 2.7MM - 1ST TRANSFIXATION MTP FUSION PLATE RIGHT - 10°
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8396375
• Report Number: 2027754-2019-00004
• Device Sequence Number: 19414770
• Product Code: HRS
• UDI-Device Identifier: 00845694041850
• UDI-Public: 00845694041850
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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: 336-2777
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 02/21/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/25/2019; 06/20/2019
• 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