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

Other: infection, sensory and motor dysfunction.The following products were used in the 28 patients covered in this clinical study: product id: 7543535, 510(k): k031655, udi: (b)(4), qty: 1.Product id: 7543540, 510(k): k031655, udi: (b)(4), qty: 1.Product id: 75445535, 510(k): k042025, udi: (b)(4), qty: 3.Product id: 75445540, 510(k): k042025, udi: (b)(4), qty: 2.Product id: 75446535, 510(k): k042025, udi: (b)(4), qty: 5.Product id: 75446540, 510(k): k042025, udi: (b)(4), qty: 13.Product id: 75446545, 510(k): k042025, udi: (b)(4), qty: 13.Product id: 75446550, 510(k): k042025, udi: (b)(4), qty: 5.Product id: 75446555, 510(k): k042025, udi: (b)(4), qty: 1.Product id: 75447535, 510(k): k042025, udi: (b)(4), qty: 1.Product id: 75447540, 510(k): k042025, udi: (b)(4), qty: 6.Product id: 75447545, 510(k): k042025, udi: (b)(4), qty: 9.Product id: 75447550, 510(k): k042025, udi: (b)(4), qty: 6.Product id: 75447555, 510(k): k042025, udi: (b)(4), qty: 3.It is unknown which of the above implants were responsible for the adverse events.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

Patient demographics: no of patients: 28; gender: (male:22; female:06); age(mean): 53.9 years, weight(mean): 86.3kgs; height(mean): 179 cms; current smoker: yes (00 patient), no (10 patients), unknown (18 patients) diagnosis- fracture (25 patient), burst fracture (3 patient) groups discussed in this study: leg_v004: multi-axial or sagittal adjusting screw leg_v011: fixed angle screw it was reported per a clinical study titled ¿clinical outcomes and safety of leg_v004 and leg_v011 with minimum 12 months follow up" that 28 patients were diagnosed with fracture and burst fracture from jan 2014 to jan 2018.These patients were treated with leg_004 during the above mentioned timeframe.1 patient treated with leg_v011 also received leg_v004.Post-operatively, after 12 months follow-up, 3 patient reported sensory dysfunction, 1 motor dysfunction and 6 patient reported both sensory and motor dysfunction.One patient suffered from 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: 9174356
• MDR Text Key: 173929235
• Report Number: 1030489-2019-01142
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 54 YR
• Patient Weight: 86