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

Catalog Number	7100-ZB18
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	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation were inconclusive based on the information available and the evaluation of the x-ray.Patient compliance following implantation of the device is unknown.Several additional patient factors were present which could have negatively impacted the outcome of the surgery.These factors include thyroid disease, depression, smoking, and complex surgical history resulting from a motor vehicle crash.The dynaforce staple and motoband max plate were used in combination with competitor product (lag screw across the joint and allograft in the fusion site).The mechanical factors associated with the combination of these additional devices are unknown.The bone fixation plate was used in conjunction with plate screws (part number - 1500-3518, lot-101414 & part number - 1500-3520, lot 101415) as well as a dynaforce bone fixation staple implant (part number 7118-1818kt, lot-500009).Additionally, the construct included a lag screw and allograft which was made by a different manufacturer.
Event or Problem Description
Plate and staple construct was implanted (b)(6) 2017.During routine follow up visits, it was noted that there was pain during examination and a lack of bony union.The construct was explanted during a revision surgery on (b)(6) 2017 due to the non-union of the fusion site.During removal of the hardware, the doctor mentioned the implants felt loose in the bone.Based on x-ray, the screw appears to have loosened and backed out of the hole, thus causing the plate to loosen.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE/ BONE PLATE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8465534
• Report Number: 3011421599-2018-00001
• Device Sequence Number: 3026705
• Product Code: HRS
• UDI-Device Identifier: 00815432023639
• UDI-Public: 00815432023639
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2018

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: No Information
• Device Catalogue Number: 7100-ZB18
• Device Lot Number: 102018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 03/29/2019
• 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: 52 YR