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

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.

• 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 Key: 10204863
• MDR Text Key: 197780317
• Report Number: 1030489-2020-00742
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/29/2020
• 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
• Date Manufacturer Received: 05/30/2020
• 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 Number: 1