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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC.; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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 in the literature titled ¿cervical pedicle screw (cps) insertion using o-arm-based 3d navigation: technical advancement to improve accuracy of screws¿ that 64 patients (31 men and 33 women) was pre-operatively diagnosed with the followings: 16 with rheumatoid arthritis, 14 with destructive spondyloarthropathy, 8 with metastatic tumor, 8 with trauma, 4 with ossification of posterior longitudinal ligament, 3 with cervical kyphosis, 3 with cerebral palsy, 3 with cervical spondylotic myelopathy, 2 with atlantoaxial osteoarthritis, 2 with atlantoaxial subluxation with unknown pathology, and 1 with klippel-feil syndrome and underwent cervical spine surgery in the spine level of c2 to c7 with cps using the intraoperative o-arm system between june 2013 and february 2020.Mean age at surgery was 67 years.Surgical technique improved in line with advances in the development of surgical instruments.Therefore, the patients were divided into 4 surgical groups based on surgical procedures.Screw accuracy was evaluated on postoperative computed tomography images.Screw accuracy was assessed using neo classification: grade (g) 0, no perforation; g1, perforation 2 mm; g2, perforation 2-4 mm; and g3, perforation 4 mm.Complications related to screw mal-positioning were also evaluated.A total of 317 cpss were placed in the spine level of c2 to c7.Eighty-three screws were placed in the first phase, 60 in the second phase, 87 in the third phase, and 87 in the fourth phase.Twelve of the 317 (3.8%) screws were mal-positioned.All 12 screws were mal-positioned in g1, and there was no g2 and g3 mal-positioning.Screw mispositioning in each phase was 6.0% (5/83) in the first phase, 8.3% (5/60) in the second phase, 1.2% (1/87) in the third phase, and 1.2% (1/87) in the fourth phase (p 0.05).Ten screws were mal-positioned laterally in phase 1 and 2, and 2 screws were mal-positioned medially in phase 3 and 4.No complications related to screw placement were observed.
 
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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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10204863
MDR Text Key197780317
Report Number1030489-2020-00742
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 05/30/2020
Initial Date FDA Received06/29/2020
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 Initial
Patient Sequence Number1
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