MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE

Catalog Number	7R50-5018
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cause of malfunction is undetermined.Device has not been received.Surgeon has not been able to be reached for comment.On 03/21/2019- a submission attempt was initially made for this mdr on (b)(6) 2018.The acknowledgement was viewed on fda webtrader.The status was noted as delivered under the acknowledgement and sent details section.The arrow button for the html download was not noticed and the submission error was not seen.The error message was for exceeding the max character count.The information that was previously listed has been posted below.The plate listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.Nitinol staple implant - dynaforce himax implant, pn-7118-1414kt, lot-102892, udi-(b)(4).Plate locking screw 3.0mm x 8mm, pn-1500-3008, lot-101299, udi-(b)(4).Plate locking screw 3.0mm x 12mm, pn-1500-3012, lot-101423, udi-(b)(4).Plate locking screw 3.0mm x 14mm, pn-1500-3014, lot-102355, udi-(b)(4).Plate locking screw 3.0mm x 18mm, pm-1500-3018, lot-101426, udi-(b)(4).Plate non-locking screw 3.0mm x 18, pn-1500-3518, lot-102345, udi-(b)(4).Plate non-locking screw 3.0mm x 18, pn-1500-3518, lot-500084, udi-(b)(4).
Event or Problem Description
A dynaforce clip and mpj plate construct was implanted in the patient on (b)(6) 2018.During a 2 month follow up visit it was discovered that the plate had elevated from the bone and a non-union was present at the fusion site.On (b)(6) 2018, the dynaforce construct was removed and another plate was implanted.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8443473
• Report Number: 3011421599-2018-00004
• Device Sequence Number: 354829
• Product Code: HRS
• UDI-Device Identifier: 00815432025039
• UDI-Public: 00815432025039
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K160300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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 Expiration Date: 02/21/2020
• Device Catalogue Number: 7R50-5018
• Device Lot Number: 500192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 03/22/2019
• 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
• Patient Age: 62 YR