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

Model Number 15LP-3536

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The surgeon reported on 5/7/2021 that the patient's anti-drift bolt backed out.The patient is asymptomatic, and no revision is planned.X-ray on (b)(6) 2021 shows that the adb head is prominent above the plate.The tip of the adb is in the 2nd metatarsal base and not the lateral cortex of the 2nd metatarsal.No non-conformances were identified.Potentially, force from weight-bearing with normal walking motion caused the screw to back-out.The following implants were also included in the contruct with the anti-drift bolt: ref: 7100-lp18-r, ln: 501209, qty: 1, product name: dynabunion plate 18mm - right.Ref: 1500-3518, ln: 400025, qty: 1, product name: motoband non-locking screw 3.5mm x 18mm.Ref: 1500-3516, ln: 400148, qty: 1, product name: motoband non-locking screw 3.5mm x 16mm.Ref: 15pl-3516, ln: 400165, qty: 1, product name: motoband polyaxial locking screw 3.5mm x 15 mm.

Event Description

The surgeon reported on (b)(6) 2021 that the patient's adb backed out.The patient is asymptomatic, and no revision is planned.X-ray on (b)(6) 2021 shows that the adb head is prominent above the plate.The tip of the adb is in the 2nd metatarsal base and not the lateral cortex of the 2nd metatarsal.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Type of Device: 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: 15501698
• MDR Text Key: 306256995
• Report Number: 3020584246-2022-00053
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432028825
• UDI-Public: 00815432028825
• Combination Product (y/n): N
• PMA/PMN Number: K193452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: 15LP-3536
• Device Catalogue Number: 501166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other