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

Model Number MSB_UNK_SCREW

Device Problems Break (1069); Biocompatibility (2886)

Patient Problems Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 09/09/2020

Event Type  Injury  

Event Description

Information was received from a patient, competent authority via a manufacturer representative regarding a patient with fusion therapy.It was reported that the patient had a atlantis c5-7 anterior fusion plate placed for discs protruding onto spinal cord.Patient developed autoinflammatory disorder, erythroderma swelling and edema in tissues and skin which has not resolved and found to be allergic to two of the implant metals - nickel and titanium.There was also local swelling causing dysphagia and abnormal swelling and thickening of tissue in front of the device behind the upper esophagus on ct scan.There was no preop counselling on metal allergy or guidance on preop metal patch testing.The plate was removed.Plate and screws were planned for removal due effects of systemic metal allergy to the device components causing local and systemic allergic reaction with multiorgan impairment.Preop imaging showed a broken fixation screw in the c7 vertebra and perioperatively after the plate was removed.The fusion was found to be mobile - ie the c5-7 fusion had failed and my cervical spine is now unstable.The broken screw will have contributed to fusion failure.The broken screw had to be left in situ as there was no safe way to remove it.Patient had failure of fusion - nonunion.(possibly due to the broken screw) adverse immune response to metals in the implant.

Manufacturer Narrative

D4, g4: product identifiers unknown 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: 18189130
• MDR Text Key: 328741296
• Report Number: 1030489-2023-00792
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• 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: 10/27/2023
• 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