MAUDE Adverse Event Report: VILEX, INC. AVID PLATE SYSTEM

Model Number	ALDNC36-7U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was submitted on 02.14.20 and a receipt/acknowledgement was received from fda.However this mdr did not show when a check of the maude database was done on october 21, 2020.Help desk was contacted and vilex was told to resubmit the mdr.Below is the information that was submitted on 02.14.20.On october 28, 2019 account manager contacted vilex in regards to an avid plate (aldnc36-7u) and locking screw (asl35-22t) failure.After multiple unsuccessful attempts to gain more information regarding the complaint ((b)(4)), the complaint was closed on 01.08.20.On january 21, 2020, vilex received the plate and screw from the account manager.A new complaint was opened ((b)(4)).The account manager reported that the screw did not lock into the plate instead it passed through the hole in the plate.The plate consists of four holes.The account manager is unsure as to which hole the screw passed through.Doctor removed the screws that were implanted in the plate, removed the plate, selected a new plate and implanted the screws.Account manager reports there was no impact to the patient.Vilex is unsure if there was a delay in surgery.On january 30, 2020, vilex's quality department inspected the plate and screw.Quality assurance manager notice that the screw head showed signs of being engaged with the plate.He tested the screw in each of the holes tightening as far as possible using the instrumentation (driver and handle) which would have been used in during surgery.By using normal pressure he was unable to pass the screw through any of the holes.A review of prior complaints, non-conformances and capas resulted in no records found regarding the plate and screw listed above.A review of prior complaints, non-conformances and capas resulted in no records found regarding the issue listed above.These devices are only marketed in the us.No additional notification are to be made to other countries or jurisdictions.
Event or Problem Description
Complaint involves an avid plate and locking screw.The locking screw did not lock into the plate.The screw was driven through the plate.

• Brand Name: AVID PLATE SYSTEM
• Common Device Name: AVID PLATE
• Manufacturer (Section D): VILEX, INC.; 111 moffitt street; mcminnville 37110
• MDR Report Key: 10742360
• Report Number: 1051526-2020-00001
• Device Sequence Number: 16882429
• Product Code: HRS
• UDI-Device Identifier: 00841731116291
• UDI-Public: 00841731116291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: ALDNC36-7U
• Device Lot Number: 9913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1