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

Catalog Number	7752536
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.During the revision surgery, it was also discovered that both connectors had separated from the original construct and also the rod crosslink's center hex was also loosened.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.
Additional Manufacturer Narrative
Product analysis results: visual functional visual inspection of the crosslink confirmed some witness marks on the outer arm and on the set screw ends where it holds the rods.Functional inspection confirmed the set screws would thread in and a sample rod confirmed the crosslink would attach and hold a sample rod with no issues.The implant appears to function as intended.No fault found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8463257
• Report Number: 1030489-2019-00341
• Device Sequence Number: 14197641
• Product Code: KWP
• UDI-Device Identifier: 00613994239273
• UDI-Public: 00613994239273
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 7752536
• Device Lot Number: 0676714W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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; Required Intervention