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

Catalog Number 5531142

Device Problem Positioning Problem (3009)

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

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 5541142, 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 degenerative scoliosis; and underwent placement of screw and hook at t4-s2ai.Posterior lumbar interbody fusion at l2-l3 and l5-s1 was also being performed.Intra-op, while making an attempt to place the extended body hook on the transverse process of t4 from the cranial side and the ramped lamina hook from the caudal side to the transverse process or lamina of t5, the ramped lamina small hook did not fit in well.Even though it was replaced with the one of middle size, the new one did not fit in as well.Although confirmation had been made using a trial before placing the hook, the hooks on the t4 caudal side could not be placed.Therefore, only the extended body large hook was set.It was a fixation of long rod, and the rod on the cranial side appeared to be a little unstable and there was a possibility that a large load was applied to the hook on the t4 cranial side.The two hooks that could not be placed on the caudal side of the t4 were on the right.It was said that there was a possibility that the base of the transverse process broke off at that time.No patient complications were reported as a result of this event.

• 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: 9685111
• MDR Text Key: 178382028
• Report Number: 1030489-2020-00157
• 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: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5531142
• Device Lot Number: 0531565W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2016
• 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