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

Model Number 55850047545

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Numbness (2415)

Event Type  malfunction  

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.

Event Description

Information was received from consumer and health care professional (hcp) via manufacturing representative regarding an event identified post op a l4-s1 tlif in a patient diagnosed with lumbar discectomy.It was reported that pedicel screw was loosening.After surgery patient noticed that during mornings numbness is returning and also the feeling of a wishbone being pulled apart.Pain is consistent but fluctuating.Based on the radiographic studies by hcp, postsurgical changes are again noted status post l4-s1 transforaminal lumbar interbody fusion, l4-l5 and l5-s1 discectomy with interbody cages at l4-l5 and l5-s1.Additional postsurgical changes are noted from right-sided hemilaminectomy at l4-l5.Hardware is intact without evidence of periprosthetic fracture.However, there is redemonstrations of lucency/osteolysis surrounding the l4 pedicle screws bilaterally, right greater than left with findings mildly progressed when compared to 10/27/2022.Findings are concerning for hardware failure/loosening.The remaining hardware demonstrates no evidence of periprosthetic fracture or osteolysis.Vertebral body heights are preserved.Intervertebral disc space heights are preserved.An s1-s2 intervertebral disc is again seen.There is redemonstrations of approximately 5 mm of retrolisthesis of l5 on s1 and stable from prior.Otherwise, lumbar spinal alignment is maintained.There is no evidence of acute fracture or traumatic malalignment.Chronic, healed l2 and l3 transverse process fractures are noted.No suspicious osseous lesions are seen.No significant degenerative changes are seen throughout the visualized portions of the upper to mid lumbar spine.Endplate degenerative changes are noted to the inferior l4 and superior l5 endplates.No definite abnormalities are seen throughout the posterior paraspinal soft tissues although sensitivity for detailed evaluation is decreased injury to adjacent streak artifact.The included retroperitoneal structures demonstrate no acute abnormalities.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ 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: 15985627
• MDR Text Key: 308382101
• Report Number: 1030489-2022-01116
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169745353
• UDI-Public: 00643169745353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55850047545
• Device Catalogue Number: 55850047545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Date Device Manufactured: 05/18/2021
• 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: 55 YR
• Patient Sex: Male