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

Model Number	7753500
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- myelopathy involved in the posterior cervical fusion procedure.It was reported that during procedure, while torquing the mas locking screw, it breaks the bottom mas connector.They could not remove this broken setscrew once it¿s broken.The bottom of the mas connectors x4 are still in the patient body as they have been stripped during insertion of crosslinks x2.Product was utilized correctly according to the directions given in the ifu/labeling.There were no patient symptoms or complications reported as a result of this event.On 2022-jan-18, received additional information that lot numbers for the reported products are not available.There was a delay in surgery, it would have been about 15 minutes.None of the actual crosslinks broke, it was the setscrew that breaks when it is final torqued.No revision surgery scheduled.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13288029
• Report Number: 1030489-2022-00052
• Device Sequence Number: 17213607
• Product Code: KWP
• UDI-Device Identifier: 00613994448743
• UDI-Public: 00613994448743
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082728
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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: 7753500
• Device Catalogue Number: 7753500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown