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
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 8564176
• Report Number: 1030489-2019-00496
• Device Sequence Number: 2339286
• Product Code: NKB
• UDI-Device Identifier: 00643169501157
• UDI-Public: 00643169501157
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Catalogue Number: 54750014530
• Device Lot Number: H5389774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1