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

Catalog Number 1606300500

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 1606200500, 510k # k131321; udi# (b)(4) was cleared in the united states.Product analysis: a visual and a microscopic review of all parts returned indicated that the two bigger screws and two of the set screws had heavy witness marks from the rod moving in between the two components.From witness marks on the rods, it appears that these two screws were located on the end of the construct.One of the bone screws has a witness mark on the head of the screw indicating that the rod came in contact with the head.This is consistent with the angulation of the rod and bone screw head.There are also witness marks on the shaft of the bone screw from where the bone screw head was sitting fully angulated.The other items returned did not appear to have issues.It appears the steep angulation between the two screws and rods could have led to the set screw loosening.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent anterior vertebral body replacement surgery and posterior fixation at t4-s2ai due to vertebral body collapse at l4.On an unknown date, post op, set screw on the caudal side totally backed out from the screw head at s1/s2ai.Since on one side, the direction of the screw head at s1 and the screw head at s2ai were different, it was difficult to have back out issue, but all the four set screws still backed out.The patient also had pain in the lower back due to set screw backing out.Hence, the patient underwent a revision surgery, in which screw replacement and fusion for extending the rod was performed.

• 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: 8606994
• MDR Text Key: 144935791
• Report Number: 1030489-2019-00538
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1606300500
• Device Lot Number: 0521318W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SCREW, SET SCREW
• Patient Outcome(s): Required Intervention