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

Catalog Number X0212513

Device Problem Material Deformation (2976)

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

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

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 underwent scoliosis correction surgery at t3-l3.The patient had a stiff double major scoliotic curve.Intra-op, when surgeon applied force to the segmental derotators, the screw head got deformed in the coronal plane; which ultimately plowed through the lateral vertebral wall of left side l2 (away from the spinal cord).The screw was then completely explanted.This level was left un-instrumented after the event.No patient complications were reported.

Manufacturer Narrative

Product analysis: visual and optical inspection did not reveal any damage to the head or threads of the bone screw.Dimensional check confirmed the bone screw was made to print.It was not possible to determine root cause of the event.If information is provided in the future, a supplemental report will be issued.

• 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: 8678017
• MDR Text Key: 147311035
• Report Number: 1030489-2019-00611
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169606951
• UDI-Public: 00643169606951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X0212513
• Device Lot Number: 0677130W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• 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 Age: 11 YR
• Patient Weight: 44