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	No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon implanted a short minibunion plate on 4/13/2020.Ten (10) weeks post-operative x-ray show that the joint has not healed.The bunion correction includes a large shift in a larger patient.The surgeon states that the joint too much dorsiflexion which may not heal.The patient has increased pain and swelling over the past 4 weeks due to increased range of motion; pain and swelling resolved at 10 weeks.The original minibunion implant was removed (b)(6) 2020.The surgeon replaced the original implant with a longer minibunion implant and placed a biocritical screw.No issues occurred removing the original minibunion.Additional implants involved in the incident include: (b)(6).
Event or Problem Description
Ten (10) weeks post-operative x-ray show that the joint has not healed.The bunion correction includes a large shift in a larger patient.The surgeon states that the joint too much dorsiflexion which may not heal.

• Brand Name: MINIBUNION SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• MDR Report Key: 10353362
• Report Number: 3011421599-2020-00012
• Device Sequence Number: 14184763
• 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 Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 05/07/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 500739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/31/2020
• 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