MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM

Catalog Number 5531113

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Other: transverse process fracture.This part is not approved for use in the united states; however a like device catalog # 5541113, 510k # k132471 and udi # (b)(4) was cleared in the united states.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 presented with kyphosis; and underwent thoraco-lumbar vertebral posterior fixation.In this surgery, the pedicles were thin, and the plan was to place transverse process hooks (wide blade hooks) at t4 and t5.The medium sized hooks were chosen by trial.When the actual hooks were placed at t5, the transverse process on both sides fractured; and the hooks could no longer be placed.As hooks were already placed at t4, hook placement at t5 was skipped.This had no impact on the operation, which was completed successfully.No other patient complications were reported other than transverse processes fracture as a result of this event.

• 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: 9893278
• MDR Text Key: 186539777
• Report Number: 1030489-2020-00391
• 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: 03/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5531113
• Device Lot Number: 0475944W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2016
• 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
• Patient Outcome(s): Other