MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM

Catalog Number 55790014530

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this part is not approved for use in the united states; however, a like device with catalog # 55840014530, 510(k) # k113174 and udi # (b)(4) is approved for sale in the us.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with ossification of ligamentum flavum; and underwent posterior spinal fusion at t7-t12.On an unknown date, post-op, the screw implanted at t7 loosened.Also, stenosis occurred at the upper level of the fixation range (stenosis was around t5-t6 and t6-t7).Hence, a revision surgery was performed, in which the following procedures were performed: (i) rod and two connectors were removed.(ii) the loose screw at t7 was replaced.(iii) pedicle screw was added to t5-t6.(iv) vertebral body at t12 collapsed a little, and pedicle screw was added to l1.(v) rod placement was performed from t5 to l1.(vi) two connectors were placed.(vii) additional decompression was performed at t5-t6-t7.

• Brand Name: CD HORIZON SPINAL SYSTEM
• 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: 9772555
• MDR Text Key: 187390893
• Report Number: 1030489-2020-00238
• 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: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2021
• Device Catalogue Number: 55790014530
• Device Lot Number: 0258796W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 75