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 Bone Fracture(s) (1870); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The following products were used in the 40 patients covered in this clinical study: product id: 75444530, 510(k): k042025, 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: 8.Product id: 75445545, 510(k): k042025, udi: (b)(4), qty: 1.Product id: 75446535, 510(k): k042025, udi: (b)(4), qty: 7.Product id: 75446540, 510(k): k042025, udi: (b)(4), qty: 36.Product id: 75446545, 510(k): k042025, udi: (b)(4), qty: 78.Product id: 75446550, 510(k): k042025, udi: (b)(4), qty: 40.Product id: 75446555, 510(k): k042025, udi: (b)(4), qty: 3.Product id: 75447535, 510(k): k042025, udi: (b)(4), qty: 3.Product id: 75447540, 510(k): k042025, udi: (b)(4), qty: 20.Product id: 75447545, 510(k): k042025, udi: (b)(4), qty: 66.Product id: 75447550, 510(k): k042025, udi: (b)(4), qty: 91.Product id: 75447555, 510(k): k042025, udi: (b)(4), qty: 25.Product id: 7041870, 510(k): k040962, udi: (b)(4), qty: 1.Product id: 7041880, 510(k): k040962, udi: 00885074032221, qty: 2.Product id: 7041890, 510(k): k040962, udi: (b)(4), qty: 4.Product id: 7543535, 510(k): k031655, udi: (b)(4), qty: 1.Product id: 7543540, 510(k): k031655, udi: 00721902857997, qty: 1.Product id: 7543635, 510(k): k031655, udi: (b)(4), qty: 2.Product id: 7543640, 510(k): k031655, udi: (b)(4), qty: 8.Product id: 7543645, 510(k): k031655, udi: (b)(4), qty: 4.Product id: 7543650, 510(k): k031655, udi: (b)(4), qty: 4.Product id: 7543740, 510(k): k031655, udi: (b)(4), qty: 2.Product id: 7543745, 510(k): k031655, udi: (b)(4), qty: 6.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

Patients details: total patients: 40 (male:15, female:25); mean weight: 73.2 kgs; mean age: 57.6 years; mean height: 167.8 cms current smoker: yes (12 patients), no (26 patients), unknown (02 patients) primary diagnosis: degenerative lumbar scoliosis (34 patients), scheuermann hyperkyphosis (05 patients), m.Bechterew (01 patient) groups discussed in this study: leg_v003: multi-axial or sagittal adjusting screw leg_v010: fixed angle screw it was reported per a clinical study titled ¿clinical outcomes and safety of leg_v003 and leg_v010 with minimum 12 months follow up" that 40 patients were diagnosed with spinal deformity from jan-2014 to jan-2018.Patients who received leg_v010 (6 patients) also received leg_v003 and were therefore combined in this report.Post-operatively, 3 patients suffered from minor infection, 5 patients suffered from deep infection, and 1 patient has fractured vertebra.After 12 months of follow-up, 1 patient reported sensory dysfunction and 3 patients reported motor dysfunction, back pain was reported in 11 patients and leg pain was reported in 11 patients.

• 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: 9150601
• MDR Text Key: 167787968
• Report Number: 1030489-2019-01110
• 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: 10/03/2019

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?: No
• 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: 10/03/2019
• 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: 57 YR
• Patient Weight: 73