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
|
Other: deep infection.The following products were reported for adverse device effects in this clinical study: product id: 75446545, 510(k): k042025, udi: (b)(4), qty: 1.Product id: 75446550, 510(k): k042025, udi: (b)(4), qty: 1.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, screw malposition and deep infection was reported for 2 patients.
|
|
Search Alerts/Recalls
|
|
|