MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	G3603522
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Paralysis (1997); Spinal Column Injury (2081); Disc Impingement (2655)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with fracture-dislocation at c5; and underwent posterior fixation at c5-c6.At the stage of taking x-ray image, after performing fixation at c5-c6 and wound closure, there was a suspicion that the screw on the right side of c6 had deviated towards the direction of va (vertebral artery).So, a ct scan was performed, and it was confirmed that the screw had deviated towards the direction of va.Mri was also performed and there were no va injury or occlusion found.A revision surgery was performed on the same day and the screw was completely explanted.There was no bleeding and wound closure was continued to be performed.Then, herniation at c5-c6 prolapsed after the operation, and laminoplasty was performed in the revision surgery on (b)(6) 2020.
Event or Problem Description
On (b)(6) 2020, the deviated screw (which was implanted at c5-c6 on the right side) and the rod were removed on the same day they were implanted.Additional screw insertion was not performed.On (b)(6) 2020, herniation was found between c5 and c6.Paralysis was observed in the lower limbs.Hence, a revision surgery was performed for the herniation.In the revision surgery, herniation removal and laminoplasty were performed.After that, the paralysis in the patient's lower limbs was resolved and there was no information such as health damage in the patient.
Additional Manufacturer Narrative
H10: x-ray review results: an axial ct shows for a posterior cervical spinal instrumentation is performed.Ct localizer indicates this is the c6 level.At the level, cervical pedicle screws have been placed.One of the screws appears in the correct trajectory, the other screw is in the vertebral artery foramen.Additional information: b5, h6, h10 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9879480
• Report Number: 1030489-2020-00369
• Device Sequence Number: 525302
• Product Code: KWP
• UDI-Device Identifier: 00643169542280
• UDI-Public: 00643169542280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: G3603522
• Device Lot Number: H5560577
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR