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

Model Number	15LP-3532
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon submitted a case series of dynabunion system.The anti-drift blot has backed out as shown in the 6-week x-ray.The screw head prominent above the plate.The patient was asymptomatic and revision surgery was not scheduled at the time of the report.The surgeon reported at a later date that the anti-drift bolt was removed.The patient is fused and walking well after the removal.Lot history records (lhr's) of the plate was reviewed.Non-conformance was not identified based on the lots that would contribute to this failure mode.Potentially, force from weight-bearing with normal walking motion caused the screw to back-out.Screw back-out is a known failure mode of screws.Refer to lot number below for additional components of the construct.Only the anti-drift bolt was removed.Ref: 7100-lp18-l, ln: 501121, qty: 1, product name: dynabunion left plate 18mm.Ref: 7118-1814kt, ln: 300280, qty: 1, product name: 18x18x14mm himax clip.Ref: 15lp-3532, ln: 501164, qty: 1, product name: dynabunion antidrift bolt 32mm.Ref: 15nl-3020, ln: 400142, qty: 1, product name: 20mmx3.0mm screw.Ref: 7118-1814kt, ln: 400148, qty: 1, product name: 16mm x 3.5mm screw.Ref: 1500-3526, ln: 400049, qty: 1, product name: 26mm x 3.5mm screw.
Event or Problem Description
The surgeon submitted a case series of dynabunion system.The anti-drift blot has backed out as shown in the 6-week x-ray.The screw head prominent above the plate.The patient was asymptomatic and revision surgery was not scheduled at the time of the report.The surgeon reported at a later date that the anti-drift bolt was removed.The patient is fused and walking well after the removal.

• 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: 12962885
• Report Number: 3011421599-2021-00013
• Device Sequence Number: 5424634
• Product Code: HRS
• UDI-Device Identifier: 00815432028801
• UDI-Public: 00815432028801
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 04/24/2022
• Device Model Number: 15LP-3532
• Device Catalogue Number: 15LP-3532
• Device Lot Number: 501164
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female