MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7750346

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Procedure: extension of previous cervical fusion levels implanted: c1-t2 it was reported that on an unknown date, post-op, follow up x-rays of patient showed the axial connector had disconnected on one side.Patient underwent revision surgery for the replacement of the implant.All the malfunctioned implants have been removed during the revision surgery and single rods construct have been implanted.Patient suffered with unstable cervical spine as a result of this event.

Manufacturer Narrative

Product analysis results: visual optical functional visual and optical inspection confirmed the outer surface has some witness marks.Functional inspection confirmed the screws were hard to loosen.Optical inspection confirmed the screw has been deformed on the ends.Root cause of the rod backing out of the connector is undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8463243
• MDR Text Key: 140274274
• Report Number: 1030489-2019-00339
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994244505
• UDI-Public: 00613994244505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7750346
• Device Lot Number: 0078708W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention