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

Model Number	Implant, 3.5mm x 36mm Anti-Drift Bolt
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter states that the surgeon has 2 dynabunion patients ((b)(6)) 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 or Problem Description
The reporter states that the surgeon has 2 dynabunion patients ((b)(6)) 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
• Common Device Name: 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: 15501617
• Report Number: 3020584246-2022-00058
• Device Sequence Number: 14773767
• Product Code: HRS
• UDI-Device Identifier: 00815432028825
• UDI-Public: 00815432028825
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: Implant, 3.5mm x 36mm Anti-Drift Bolt
• Device Catalogue Number: 15LP-3536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown