MAUDE Adverse Event Report: OSTEOMED EXTREMIFUSE; 2.0MM X 10° EXTREMIFUSE IMPLANT

Catalog Number	319-1020
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the lack of fusion after 10 plus months regarding the 2.0mm x 10° extremifuse implant (p/n (b)(6)), could not be determined.The possibilities are numerous including a non-compliant patient, poor bone quality or quantity, broken implant, user errors by the implant surgeon, active infections in the patient, high-levels of activity, etc.There was no lot number provided.Therefore, a review of the device record associated with this particular device could not be performed.A two-year review did not identify any capa or ncr investigations for this device.A two-year review of complaints did not show any additional complaints related to this implant.This implant is a single use device within the extremifuse system.Per the extremifuse risk document, the risk of the loss of fixation postoperatively has a severity rating of 3.Per the risk management procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).The predicted risk level is "low".The extremifuse instructions for use (ifu) has multiple warnings, instructions, and contraindications regarding the implant.The surgical technique guide (stg) for the extremifuse system also shows the proper steps to implant the extremifuse implant.This issue will be monitored through routine trending.
Event or Problem Description
On (b)(6) 2018, osteomed was notified of an adverse event related to the 2.0mm x 10 extremifuse implant (p/n (b)(4)).Per the information received, the distal part of the implant did not catch properly, so a surgery was performed on (b)(6) 2018 to remove it.

• Brand Name: EXTREMIFUSE
• Common Device Name: 2.0MM X 10° EXTREMIFUSE IMPLANT
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7981393
• Report Number: 2027754-2018-00040
• Device Sequence Number: 13498311
• Product Code: HWC
• UDI-Device Identifier: 00845694052191
• UDI-Public: 00845694052191
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K130412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 319-1020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/18/2018
• 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