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

Catalog Number G6956424

Device Problem Malposition of Device (2616)

Patient Problem Rupture (2208)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 6958724; udi# (b)(4); 510k # k083071 was cleared in the united states.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient underwent posterior cervical spinal fusion surgery at c5.Post-op, next day evening, neurological symptom occurred to the patient.Although the direct reason of neurological symptom was diagnosed as hematoma, it was reported that the screw was malpositioned that caused rupture of medial side of the pedicle.The extraction surgery was decided to be performed to remove the screw.Although medial rupture was not the direct reason of neurological symptom, it was said that pedicle screw was decided to be removed as well since it was necessary to remove the hematoma.The unilateral fusion was performed with pedicle screw (ps) at c5 and lateral mass screw (lms) at c6 only on the right side during initial surgery.During revision surgery, pedicle screw which was inserted at c5 was removed.Lateral mass screw was added to be inserted at c4 and re-fixation was performed at c4-6 after removing the hematoma and performing bone graft.According to the healthcare professional's opinion, the reported event is not related to use of medtronic products.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7240874
• MDR Text Key: 98996557
• Report Number: 1030489-2018-00163
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2018

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 Catalogue Number: G6956424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/05/2018
• 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
• Patient Outcome(s): Required Intervention