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

Catalog Number	7100-RP15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plate was used in combination with a nitinol clip implant, and together functioned as one total construct, in order to provide compression to better facilitate the fusion process.One of the clips used has also been confirmed to have experienced mechanical failure.The clips that were used are listed below: part number: 7115-1515kt lot number: 500145; part number: 7115-1515, lot number: 500173.
Event or Problem Description
Date of initial surgery was (b)(6) 2018.The hardware was removed on (b)(6) 2018 and the site was revised.The plate and one nitinol clip implant have been confirmed to have experienced mechanical failure.No x-rays are available at this time.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8442068
• Report Number: 3011421599-2018-00006
• Device Sequence Number: 16589596
• Product Code: HRS
• UDI-Device Identifier: 00815432023684
• UDI-Public: 00815432023684
• Combination Product (Y/N): N
• 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: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 7100-RP15
• Device Lot Number: 500143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 03/21/2019
• 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: 54 YR