MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 5440030

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Muscle Weakness (1967); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's address details are unknown.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a medtronic representative regarding a patient previously implanted with screws in a fusion.It was reported that the patient has previously had spinal fusion at l2¿s1 on (b)(6)2018.They removed the original hardware on (b)(6)2021, but the fusion had taken hold and there were loose screws at s1.A new construct was placed at l2¿l3 with interbody cage which failed very quickly.This was removed on (b)(6)2022 as the cage had moved 9mm and the screws had loosened so much that they could be pulled out of the bone.A new construct was placed at l2¿l5 and monthly monitoring took place to see if fusion was taking hold, but the screws were loosening again.Ct scan on (b)(6)2022 shows that the screws were loosening with a broken screw at l4.The patient had deep pain in the lower back, an itchy back, and discomfort.Ever since the surgeries, the patient's face gets red when shaving his face.The patient is weakened, is having issues with incontinence, and swelling in affected areas.No further complications were reported/ anticipated.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 15264058
• MDR Text Key: 304960436
• Report Number: 1030489-2022-00793
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00613994790705
• UDI-Public: 00613994790705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5440030
• Device Catalogue Number: 5440030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2022
• 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 Age: 62 YR
• Patient Sex: Male