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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
Model Number MSB_UNK_ACC_SOLR
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
Clinical citation: mr (b)(6): clinical outcome and safety of cdh solera with up to 24 months follow up.A retrospective study.(b)(6) spine registry, patient¿s medical notes.Age at event: mean age 59.83 years (out of 87 patients).Sex: female (53 female and 34 male).Report source.Country: (b)(6).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
It was reported that in a clinical study for outcome and safety of cdh solera with up to 24 months follow up with 87 patients aging between 27-88 and a mean age 59.83 where 34 are male and remaining 53 are female with an indication of degenerative spinal disease in need of l1-4 spinal therapy.Cdh solera (multi-axial or sagittal adjusting screw) was used for the treatment where 24 patients using unilateral approach and remaining 63 patients using bilateral approach.A total duration of surgery was measured for 64 patients ranging between 140-450 with a mean of 205.67.Out of 86 patients, 25 had conventional open surgical access and 61 had minimal invasive surgical access.O-arm is used for image guidance system for implantation in 73 patients.Length of hospital stay is measured is between 1-39 with a mean of 4.45.Blood loss is observed in 64 patients ranging between 55-900 ml with a mean of 248.9 ml.The odi, vas back and leg pain was measured for 61 patients baseline, fu 31 patients after 6 months and fu 8 patients after 24 months.The odi baseline reduced from 18-82 (mean 57.08) to 0-78 (mean 41.35) after 6 months and to 0-74 (mean 29.12) after 24 months.The vas back pain reduced from 0-10 (mean 7.59) to 0-10 (mean 4.78) after 6 months and to 0.1-7.3 (mean 3.17) after 24 months.The vas leg pain reduced from 0-10 (mean 7.0) to 0-9.4 (mean 3.8) after 6 months and to 0.1-8.1 (mean 3.1) after 24 months.The eq- 5d healthy status and eq-5d index was measured for 41 patients baseline, fu 29 patients after 6 months and fu 9 patients after 24 months.The eq- 5d healthy status baseline has increased from 0-90 (mean 42.87) to 0-91 (mean 55.34) after 6 months and to 33-90 (mean 69) after 24 months.The eq- 5d index baseline has increased from -0.13-0.57 (mean 0.27) to -0.04-1.0 (mean 0.52) after 6 months and to 0.3-1.0 (mean 0.63) after 24 months reported events: blood loss is observed in 64 patients ranging between 55-900 ml with a mean of 248.9 ml.Out of 87, 1 patient underwent second spine surgery on initial target level after 1 year.Unilateral instrumentation l4-s1 on (b)(6) 2018, presented with mechanical loosening of l4 screw, revised with 8mm diameter screw and contra-lateral instrumentation.
 
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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
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10739387
MDR Text Key216595611
Report Number1030489-2020-01491
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/27/2020
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
Device Model NumberMSB_UNK_ACC_SOLR
Device Catalogue NumberMSB_UNK_ACC_SOLR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/09/2020
Initial Date FDA Received10/27/2020
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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