MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 55790016545

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

G4: this part is not approved for use in the united states; however a like device catalog#- 55740006545, 510(k)#- k202328 and udi#- (b)(4) was cleared in the united states.B1/b2/h1: device model-55790016545 not marketed in the us, but is similar to other marketed devices.Thus, it is reportable for malf unction, not serious injury, although surgical intervention did take place.H3 - 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 a health care professional via manufacturer representative regarding a patient with posterior lumbar i nterbody fusion.Levels implanted: l3/4/5.Pre-operative diagnosis for this procedure was lumbar spinal canal stenosis.It was reported the physician was considering a secondary surgery.The primary surgery was for (b)(6), and it was said that the posterior will be extended to a maximum of th10 to perform bone cutting.No delay in overall procedure time.No in-patient hospitalization or prolongation of existing hospitalization.There were unknown patient symptoms or complications as a result of this event.No product malfunction mentioned.No further complications reported.The reoperation was scheduled for two stage operation, of which one-stage operation was performed on november 20.There was no looseness in the screw, and there were no problems such as movement or sinking in the cage.It was judged that bone fusion had achieved by the physician's sense.The cause of reoperation was lumbar spinal canal stenosis.It was said that after the reoperation, there were no complications of the patient and the patient was in good condition.The main complaints were back pain and lower extremity pain, stenosis between l1/2/3, and l2 vertebral body collapsed on the right side.The rod of l3-5 was removed and ps was inserted into l1/2.This time, only posterior position was selected in the one-stage operation.Decompression was performed between l1/2 and l2 / 3.There was no space for inserting cage between l1 and l2, and bleeding was severe and only decompression was performed.Between l2/3, one rise cage of the topic of globus company was inserted from the right side.From l1 to l5 were connected by rod, one gc was placed and the operation had been completed.Both screws were loose, so they were removed and replaced with new ones with larger ones.In addition, the right screw dia.7.5 × 45 mars of l2 was loose, so it was removed and replaced with a new one with a larger one.The revision surgery was performed on (b)(6) 2023, however, the patient wanted to keep it so the product will not be returned.No patient complications.Rod removal, gc removal, 3 loose screws were replaced, and then ps was inserted into the upper t8hook and t9-12.Rod connected from t8 to l5.In the tlif t12-l1, catalyft was set up, gc was set up, and then the procedure was completed.

• Brand Name: CD HORIZON® SPINAL 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: 17947539
• MDR Text Key: 325822510
• Report Number: 1030489-2023-00701
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55790016545
• Device Catalogue Number: 55790016545
• Device Lot Number: H5579595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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