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

Catalog Number 5442136

Device Problem Material Deformation (2976)

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

Event Date 11/20/2018

Event Type  malfunction  

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.

Event Description

It was reported that the patient underwent thoracic fusion surgery at t1-t7 due to thoracic burst fracture.Intra-op, the surgeon had placed the crosslinks, but after he had broken off the outer set screws, he was not happy with the placement of the crosslinks.He attempted to remove the crosslinks, but the set screws of the crosslinks stripped.As he was not able to remove the crosslinks, he took out the rods with the crosslinks attached to the them.He then placed the new rods.No fragment of the stripped crosslink remained inside the patient.There were no patient symptoms or complications as a result of this event.

Manufacturer Narrative

Product analysis results: the connector was returned with a rod stuck in one side.The internal hex had been damaged to the point that a driver will no longer engage the screw head.There are two possible causes for the damage to the hex of the set screw not allowing removal.The first is that the set screw was over tightened and led to the hex damage on both the screw and the driver upon removal.The second cause could have been if the remove tool was worn before use and the driver could have turned in the screw head and caused the damage.If information is provided in the future, a supplemental report will be issued.

• 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: 8177835
• MDR Text Key: 130763065
• Report Number: 1030489-2018-01671
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994588456
• UDI-Public: 00613994588456
• 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,Followup
• Report Date: 02/17/2019

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: 5442136
• Device Lot Number: 0496605W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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
• Treatment: ROD