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

Model Number G3603530

Device Problem Use of Device Problem (1670)

Patient Problem Numbness (2415)

Event Date 06/05/2023

Event Type  Injury  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having c1/2 fixation for c1/2 subluxation.It was reported that c2 laminar screws on both sides and the right laminar screw broke into the spinal canal.It seems that it came in contact with the left nerve root.Numbness occurred on the left side. no problems during rest, but numbness occurred during movement.The initial surgery happened on (b)(6) 2023 and a revision surgery is planned on (b)(6) 2023 due to this event. c1/2, c2 laminar screw and right laminar screw were affected by spinal canal perforation numbness.Product remain in patient.Additional information received from manufacturer representative that the screw was not broken or damaged.There were no plan to explant the screw in revision surgery, but planed to change the direction.Revision surgery rescheduled to (b)(6) 2023 additional information received from manufacturer representative that the revision surgery was scheduled for today, (b)(6).The right c2 laminar screw (f3.5-30mm) was removed, and a f4.0-30mm was reinserted in a different direction.The wound was closed and the procedure was completed successfully.Additional information received from manufacturer representative that the screw was not broken, but the direction seemed no good.The explanted screw was discarded by customer.

Manufacturer Narrative

H6 - 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.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
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17236178
• MDR Text Key: 318182527
• Report Number: 1030489-2023-00471
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G3603530
• Device Catalogue Number: G3603530
• Device Lot Number: H5793372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Date Device Manufactured: 09/08/2022
• 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