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

Model Number	7576540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.Pre-operative diagnosis for this procedure was 1st diagnosis: spondylolisthesis in l5-s1.2nd diagnosis: spondylodiscitis in l5-s1.3rd diagnosis: implant failure of l5-s1.First surgery was mast transforaminal lumbar interbody fusion (tlif).Second surgery was open surgery of lumbar region (re-exploration of lumbar spine and debridement and bone grafting).Third surgery type was open surgery of lumbar region (revision fixation).Levels implanted: in first and second surgery single level implanted.However, in third surgery double levels implanted.It was reported that the screws were broken. on follow up after 1 and half month of first surgery (mast tlif), patient was diagnosed with spondylodiscitis.Therefore second surgery was performed. patient had severe lower back pain.There were no other patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
D.6a and d.6b are updated radiograhic image review results: lateral x-ray prep l5 has defect product.Post operative x-ray ap|lateral view sp l5-s1, tl1r.Hardware were appear intact.Pre operative x-ray labeled flexion.Post operative xray - l5-s1 fusion- no interbody graft is present.One of the s1 screws shows of the screw shaft and tulip.Ap|lateral xray - on the right side the tulips appear separated from both l5 and s1.Lateral xray - l5-s1 fusion construct- interbody graft at l5-s1.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: 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: 19039475
• Report Number: 1030489-2024-00237
• Device Sequence Number: 15571281
• Product Code: KWP
• UDI-Device Identifier: 00885074031132
• UDI-Public: 00885074031132
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7576540
• Device Catalogue Number: 7576540
• Device Lot Number: H5888698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/26/2024
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown