MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 5442138

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

H6: 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.

Event Description

It was reported that the patient was undergoing a revision surgery at t9-t10.Intra-op, when placing the crosslink, set screw of the crosslink stripped; so, the surgeon replaced the entire crosslink with a new one.No patient complications were reported due to this event.

• Brand Name: CD HORIZON SPINAL 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: 9435077
• MDR Text Key: 186608715
• Report Number: 1030489-2019-01399
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994588463
• UDI-Public: 00613994588463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091974
• 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
• Report Date: 12/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 5442138
• Device Lot Number: 0696797W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2019
• Initial Date FDA Received: 12/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2018
• 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 Age: 80 YR