MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. 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 Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other: infection, sensory and motor dysfunction.The following products were reported for serious adverse device effects in this clinical study: 1.Product id: 7543530, 510(k): k031655, udi: (b)(4), qty: 1.2.Product id: 75444530, 510(k): k042025, udi: (b)(4), qty: 2.3.Product id: 75445535, 510(k): k042025, udi: (b)(4), qty: 1.4.Product id: 75446535, 510(k): k042025, udi: (b)(4), qty: 1.5.Product id: 75446545, 510(k): k042025, udi: (b)(4), qty: 1.6.Product id: 75446550, 510(k): k042025, udi: (b)(4), qty: 2.7.Product id: 75447540, 510(k): k042025, udi: (b)(4), qty: 2.8.Product id: 75447545, 510(k): k042025, udi: (b)(4), qty: 3.9.Product id: 75447550, 510(k): k042025, udi: (b)(4), qty: 3.10.Product id: 75447555, 510(k): k042025, udi: (b)(4), qty: 1.Also, it is unknown whether these products caused or contributed to the reported event or not.We are filling this mdr for notification purpose.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: 21 (male: 13, female: 08); mean age: 60.6 years, mean weight: 76.5 kg; mean height: 172.1 cm social history: current smoker: yes (4 patients), no (5 patients), unknown (12 patients) primary diagnosis: spinal tumor (18 patients), m.Kahler (3 patients) groups discussed in this study: leg_v006: multi-axial or sagittal adjusting screw leg_v013: fixed angle screw it was reported in the clinical study titled ¿clinical outcomes and safety of leg_v006 and leg_v013 with minimum 12 months follow up" that 21 patients were diagnosed with spinal tumor from jan 2014 to jan 2018.Post-operatively, after 12 months follow-up, 1 patient reported sensory dysfunction and 1 patient reported both sensory and motor dysfunction.Superficial infection was reported in 1 patient while 4 patients reported deep infection.

• 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: 9182276
• MDR Text Key: 162083499
• Report Number: 1030489-2019-01135
• 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,Followup
• Report Date: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 09/10/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 76