MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 1474100500

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Infection (1930)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

The following additional products were also used in the surgery.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Item no.Product lot quantity similar device 510k udi: 10 , gx1014051, 0435581w , 2 , 5441123 , k091974 , (b)(4); 20 , gx1014051, 0435585w , 2 , 5441123 , k091974 , (b)(4); 30 , 7068397 h5326815 4 , 5440130, k102555 , (b)(4).This part is not approved for use in the united states; however, a like device with catalog # 1474000500, 510k # k091974, udi# (b)(4) is approved for sale in the us.The device has not been returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Initial surgery: mas on t2/3, hook on l2/3 pre-operative diagnosis: scoliosis it was reported that post-op, the rod was raised due to kyphosis under the skin between the superior anchor and the inline connector.Infection occurred due to decubitus to the patient at the back part of the rod.Revision surgery was performed to remove the implants.The operation time was extended for about 15 minutes because it was difficult to remove the implants.No fragment remains in the patient.The patient issue has not been resolved.No malfunction in any products were reported.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 8130148
• MDR Text Key: 129233751
• Report Number: 1030489-2018-01601
• Device Sequence Number: 1
• Product Code: NKB
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Catalogue Number: 1474100500
• Device Lot Number: 0289966W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/26/2013
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 26