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

Device Problem Malposition of Device (2616)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Others: deep infection.The following products were used in the 6 patients covered in this clinical study: product id: 75476540, qty: 2.Product id: 75476545, qty: 4.Product id: 75476550, qty: 1.Product id: 75477535, qty: 2.Product id: 75477540, qty: 6.Product id: 75477545, qty: 13.Product id: 75477550, qty: 7.Product id: 75477555, qty: 4.It is unknown which of the above implants was responsible for the reported adverse event.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

No.Of patients: 06 (male: 02, female: 04); mean weight: 78.5 kg; mean age: 59.8 years; mean height: 167.7 cm current smoker: yes (01 patient), no (04 patients), unknown (01 patient) pre-operative diagnosis: degenerative lumbar scoliosis (05 patients), m.Bechterew (01 patient) study group: fnsl_v003: multi-axial or sagittal adjusting screw it was reported per a clinical study titled ¿clinical outcomes and safety of fnsl_v003 with minimum 12 months follow up" that 06 patients were diagnosed with spinal deformity from jan-2014 to jan-2018.Post-operatively, 1 patient suffered from deep infection and malposition of screw.This patient then underwent screw re-positioning surgery at the target level.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9155079
• MDR Text Key: 167842413
• Report Number: 1030489-2019-01115
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/04/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 78