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

Model Number Implant, 3.5mm x 36mm Anti-Drift Bolt

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Malunion of Bone (4529)

Event Type  malfunction  

Manufacturer Narrative

The reporter states that the surgeon has 2 dynabunion patients (pc 0239 and pc 0240) undergoing evaluation for potential non-unions.The investigator contacted the surgeon to retrieve more information related to the alleged complaint and has not received a reply.Part numbers, lot numbers, and final prognosis is unknown at this time.No further information has been received at this time.It is unknown if patients experienced non-union; thus, the complaint has not been confirmed.

Event Description

The reporter states that the surgeon has 2 dynabunion patients (pc 0239 and pc 0240) undergoing evaluation for potential non-unions.The investigator contacted the surgeon to retrieve more information related to the alleged complaint and has not received a reply.Part numbers, lot numbers, and final prognosis is unknown at this time.No further information has been received at this time.It is unknown if patients experienced non-union; thus, the complaint has not been confirmed.

• 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: 15501563
• MDR Text Key: 306362792
• Report Number: 3020584246-2022-00057
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2022

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
• Device Operator: Health Professional
• Device Model Number: Implant, 3.5mm x 36mm Anti-Drift Bolt
• Device Catalogue Number: 15LP-3536
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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