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

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.

• 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 Key: 10739387
• MDR Text Key: 216595611
• Report Number: 1030489-2020-01491
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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 Number: MSB_UNK_ACC_SOLR
• Device Catalogue Number: MSB_UNK_ACC_SOLR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/27/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR