MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Literature citation: radiologic analysis of pedicle marker for the cervical spine by hiroshi miyamoto, terumasa ikeda, masao akagi mean age: 70.5+/-15.7 years male(22), female(17).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 "radiologic analysis of pedicle marker for the cervical spine" that a total of 228 cpss were inserted in 59 consecutive patients using either ct cutout technique or navigation.During surgery, pms(pedicle markers) were inserted, and the locations were confirmed on oblique fluoroscopic views in ct cutout technique and intra-operative ct in navigation.Intra-operative misplaced pm and postoperative misplaced cps(cervical pedicle screw) were assessed.Using the ct cutout technique, patients(22 male and 17 female) underwent posterior cervical reconstruction surgery in 2014 and 2015, which included patients with cervical myelopathy associated with local kyphosis (20), rheumatoid arthritis(6), trauma(5), tumor(4), ossification of longitudinal ligament(2), dropped head syndrome(2).The route was modified under the recognition of misplaced pedicle marker during surgery for four pedicles (3.7%, 2 at c3 and 1 at c4, and 1 at c5), and correct cervical pedicle screws (cps) placement was confirmed by postoperative ct.Only one malpositioned cps was identified (0.9%, at c5), and categorized as type 1 (medial perforation).No malpositioning of the screw occurred in the cephalocaudad direction.There were no clinical complications related to the procedures.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8459091
• MDR Text Key: 141453290
• Report Number: 1030489-2019-00330
• Device Sequence Number: 1
• Product Code: KWP
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2019

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: 03/06/2019
• Initial Date FDA Received: 03/28/2019
• 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