MAUDE Adverse Event Report: AZURMEDS INC. LTJ SCREWS; COMPRESSION BONE SCREW

Model Number	3.75 SOLID SCREW - LENGTH 40MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the event could not be determined from the information available and in absence of device evaluation.
Event or Problem Description
On postoperative radiography, the screw is bent.During the surgery, the surgeon was satisfy with the compression obtained so the surgeon decide to not report the issue.5 months later, there is no clinical impact nor consequence for the patient.However as the surgeon become aware of another similar case, he report the issue to us.

• Brand Name: LTJ SCREWS
• Common Device Name: COMPRESSION BONE SCREW
• Manufacturer (Section D): AZURMEDS INC.; 4809 n ravenswood avenue; suite 119; chicago IL 60604
• MDR Report Key: 12182082
• Report Number: 3016605123-2021-00001
• Device Sequence Number: 17256834
• Product Code: HWC
• UDI-Device Identifier: 00810041621375
• UDI-Public: (01)00810041621375(11)200921(10)2001PP37
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.75 SOLID SCREW - LENGTH 40MM
• Device Catalogue Number: 81004162137
• Device Lot Number: 2001PP37
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/16/2021
• 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: Other