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

Model Number	3.75 SOLID SCREW - LENGTH 36MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the same procedure, a second screw has been used and also bent : ltj 3.75mm solid ss screw l.38mm - udi: (b)(4).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 2 screws are bent.During the surgery, the surgeon was satisfy with the compression obtained.There is no clinical impact nor consequence for the patient.

• 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: 12182107
• Report Number: 3016605123-2021-00002
• Device Sequence Number: 4454389
• Product Code: HWC
• UDI-Device Identifier: 00810041621351
• UDI-Public: (01)00810041621351(11)200921(10)2001PP35
• 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 36MM
• Device Catalogue Number: 81004162135
• Device Lot Number: 2001PP35
• 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
• Patient Age: 19 YR
• Patient Weight: 104