MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Literature citation: titled- single center retrospective evaluation of intraoperative/peri-operative adverse events associated with the fenestrated screw when used in the treatment of patients with spinal tumors by ilya laufer, md.Age at event: age distribution was 19 to 87 years, with an average age of 61.4 years.Sex:gender distribution was 23 females and 30 males.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.

Event Description

It was reported in the literature study titled ¿single center retrospective evaluation of intraoperative/peri-operative adverse events associated with the fenestrated screw when used in the treatment of patients with spinal tumors¿ that a total of 53 patients were treated for 67 fractures (thoracic t3-t10:20; thoracolumbar t11-l1: 14; lumbar l2-l5: 19).13 patients had multiple fractures.Post-op, patient suffered with wound dehiscence requiring debridement during the 60 day post-op follow-up.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7181512
• MDR Text Key: 96933604
• Report Number: 1030489-2018-00047
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/11/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76