MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION SYSTEM; PLATE, FIXATION, BONE

Model Number	3100-0030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient underwent removal surgery approximately 9 months after implantation due to prominence due to exostosis.The patient was asymptomatic prior to removal surgery.The patient has no known allergies.During the removal, the surgeon observed black soft tissue (metallosis) in the entire canal and the surface of the minibunion plate.The implant was removed without complication.Review of product records confirm all components conform to astm f136 ti-6al-4v titanium alloy.No nonconformance was identified.
Event or Problem Description
The patient underwent removal surgery approximately 9 months after implantation due to prominence due to exostosis.The patient was asymptomatic prior to removal surgery.The patient has no known allergies.During the removal, the surgeon observed black soft tissue (metallosis) in the entire canal and the surface of the minibunion plate.The implant was removed without complication.

• Brand Name: MINIBUNION SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 10557692
• Report Number: 3011421599-2020-00015
• Device Sequence Number: 2793722
• Product Code: HRS
• UDI-Device Identifier: 00815432027149
• UDI-Public: 00815432027149
• Combination Product (Y/N): N
• PMA/510(K) Number: K190658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: No Information
• Device Expiration Date: 05/09/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 500737
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 09/19/2020
• 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