MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 54750014530

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review result: post-op ct show a thoracic construct with bi-cortical purchase of both screws at this level.Insertion distance and screw length is determined by the performing surgeon and no hardware failure is present in this image.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre operative diagnosis for this procedure: dislocation fracture at t5-t6 type of procedure or technique used: t3-t4 and t6-t7 percutaneous pedicle screw (pps) fusion it was reported that intra-op, due to unavailability of 4.5mm x 25mm screws, 4.5mm x 30mm screws were inserted forcibly using o-arm navigation.As a result, the screws on both sides of t3 protruded the anterior wall of the vertebral body, causing an event that hit the lung and the thoracic aorta.No patient complications were reported but it was nearly a catastrophe.Final tightening was performed forcibly with the construct.There was a delay of less than 60 minutes in the overall procedure time.No injury to the patient was reported.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8564166
• MDR Text Key: 143544883
• Report Number: 1030489-2019-00495
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169501157
• UDI-Public: 00643169501157
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54750014530
• Device Lot Number: H5389774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2017
• 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