MAUDE Adverse Event Report: VILEX LLC VILEX AVID PLATE; AVID MTP PLATE

Model Number	AMP53-10L
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On january 8, 2021, vilex received a broken avid plate, amp53-10l, from account manager.Account manager was contacted and asked to complete an issue review form.Account manager returned the completed form that same day.Account manager stated that the patient had mtp arthrodesis surgery on (b)(6) 2020.Upon post-op evaluations the doctor detected movement at the fusion sight.Results of x-rays performed it was discovered that the plate was broken.Upon questioning the patient it was discovered that the patient had tripped bearing excess weight and force at the surgical site.Account manager stated that the patient is a very tall man and is neuropathic, which causes him to feel no pain.Due to being neuropathic, the patient did not feel any pain when he tripped.Patient was scheduled for surgery on (b)(6) 2020.The patient was removed with no complications.The doctor applied a ex-fix rail to the surgical site.On january 14, 2021, vilex quality department examined the broken plate and the account manager's statement.Examination of the broken plate by vilex quality department resulted in no findings of an improper surgical technique.Upon further examination, the screw holes located in the plate showed no signs of distortion or misalignment.Vilex quality found no issues with the plate.Vilex also reviewed complaints, non-conformances and capa's from 2017 to present.No records were found for vilex avid plate amp53-10l.Avid plate system is only marketed in the united states, therefore, no additional regulatory notification is needed.Should more information become available vilex will file a supplemental report.
Event or Problem Description
During post-op visit it was deteremined that the avid plate had broken.

• Brand Name: VILEX AVID PLATE
• Common Device Name: AVID MTP PLATE
• Manufacturer (Section D): VILEX LLC; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 11290271
• Report Number: 1051526-2021-00001
• Device Sequence Number: 16978149
• Product Code: HRS
• UDI-Device Identifier: 00841731115942
• UDI-Public: 00841731115942
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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 Model Number: AMP53-10L
• Device Lot Number: 9087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1