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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Multiple devices were involved in the event.Since we cannot determine which of the devices led to the event, we are filing this report for notification purposes.Following devices are suspected to have contributed to the event: lot # 5432141, (b)(4), 5432147, (b)(4).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.These parts are not approved for use in the united states; however, a like device catalog # 5442141, 510k # k091974 and upn# (b)(4) was cleared in the united states.

Event Description

Pre-op diagnosis: burst fracture at thoraco-lumbar junction part (fixation: 2a2b) procedure: posterior spinal fusion levels implanted: t10-l2 it was reported that on an unknown date, post-op, the part of the skin where the crosslink had been placed was damaged.The damaged site was at the stage prior to pressure ulcer.There was also pain due to protrusion of the device.Patient underwent a revision surgery for removal of all the implants.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6379662
• MDR Text Key: 69094461
• Report Number: 1030489-2017-00463
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2013
• 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
• Treatment: SET SCREWS, SCREWS, RODS
• Patient Outcome(s): Other