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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
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.
 
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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 Key9155079
MDR Text Key167842413
Report Number1030489-2019-01115
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
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 Received10/04/2019
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 Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age59 YR
Patient Weight78
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