MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	7100-LP18-L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2022, the surgeon removed dynabunion implants that were implanted (b)(6), 2021.Implants were removed per patient request due to prominence leading to irritation.Hardware was removed and not replaced.Union was present.
Additional Manufacturer Narrative
On (b)(6), 2022, the surgeon removed dynabunion implants that were implanted (b)(6), 2021.Implants were removed per patient request due to prominence leading to irritation.Hardware was removed and not replaced.Union was present.Implants were not returned for analysis.Review of production records did not identify non-conformance for the components removed.In addition to the dynabunion plate, the following screws and staple were removed as part of the overall construct: ref: 15lp-3532 ln: 501185 qty: 1 product name: dynabunion anti-drift bolt, ref: 7118-1818 ln: 501403 qty: 1 product name: himax 18mm x 18mm x 18mm, ref: 1500-3518 ln: 400186 qty: 1 product name: motoband non-locking screw 3.5mm x 18mm, ref: 15pl-3518 ln: 400166 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 18mm, ref: 15pl-3530 ln: 501040 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 30mm.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr.; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 14478311
• Report Number: 3020584246-2022-00002
• Device Sequence Number: 5336027
• Product Code: HRS
• UDI-Device Identifier: 00815432028788
• UDI-Public: 00815432028788
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

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 Expiration Date: 05/13/2025
• Device Model Number: 7100-LP18-L
• Device Catalogue Number: 7100-LP18-L
• Device Lot Number: 501444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female