MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Weakness (1967); Pain (1994)

Event Type  malfunction  

Event Description

Information was received from legal regarding a patient with spinal implants.Surgery: acdf date of cervical operation: (b)(6) 2017.It was reported by the patient that the doctor operated on his neck where he confirmed a protruding disc from c3/4 through c6/7.It was reported that on unknown date, post-op, patient suffered from pain which worsened 3-4 times more than before surgery.The patient also had burning pitching and stinging sensation in his neck and worsened when he rotates the neck.X-ray mri done on (b)(6) 2018 showed c3, 4, 5, 6 are protruding by 2mm and pinching the nerves.Patient has pain running up both sides of his neck into jawbone and ear drums; it also runs across his face, cheek bones and eyes.It feels like low voltage electric current coming across his face.Clinical note id#(b)(6) reason for visit neck pain and lower back pain cc: neck pain and lower back pain hpi patient is a 53-year-old male referred to the office by the doctor for evaluation and treatment on neck pain.Patient states he has been experiencing this pain since (b)(6) 2017 after cervical surgery.Patient states that the doctor performed surgery on (b)(6) 2017 to c3-4, c6-7.Patient states he continued with pain therefore he sought medical treatment with the doctor who advised patient he willnot redo surgery.Patient states he sought medical treatment with doctors who performed mri and rf injections.Patient has had mri, has not had ct, has had x-ray, has had physical therapy, has not had ncs/emg.Patient c/o constant anterior neck pain he mentions pain radiates to jaw and bilateral ears.Patient states he has weakness to bilateral hands.Patient c/o lower back pain he mentions pain radiates to right anterior lower extremity, patient is currently taking tylenol #4 for the pain, he mentions that helps.Patient is currently rating the pain to be at a pain level of 6/10 vas.

Manufacturer Narrative

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: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15025847
• MDR Text Key: 304777974
• Report Number: 1030489-2022-00647
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• 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 Sex: Male