MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	6068093
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Paresthesia (4421)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 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 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 a healthcare provider (hcp) via manufacturer representative regarding spinal products that is used in clinical study name tlif ide pivotal study (b)(6), clinical patient id (b)(6).It was reported that the patient had left lateral lower leg paresthesia, abnormal neuro lumbar exam s1 impaired left side to light touch and pin prick.Severity of adverse event is moderate.Patient had nuerological status lumbar physical exam was conducted on (b)(6) 2024 which resulted in impaired sensory function left s1 to light touch and pin prick.Principal investigator reviewed the imaging and stated these demonstrate intact hardware posteriorly l4-s1.It appears she has subsided slightly at l4-l5 as compared to her immediate postoperative x-rays.Investigator assessed that the event has causal relationship with study procedure (l4-s1 tlif), unlikely related to tlif grafting material, possible related to intervertebral body fusion device and posterior supplemental fixation system.Sponsor assessed that the event has causal relationship with study procedure (l4-s1 tlif), unlikely related to tlif grafting material, possible related to intervertebral body fusion device and posterior supplemental fixation system.Cec assessed that the event is not related to product/therapy/procedure.Lumbosacral spinal level: yes (l5-s1) patient outcome: not recovered/not resolved additional information was received via manufacturer representative that there is no allegation or malfunction associated with posterior supplemental fixation system.

• Brand Name: CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20442671
• Report Number: 1030489-2024-01293
• Device Sequence Number: 8163940
• Product Code: MAX
• UDI-Device Identifier: 00763000246723
• UDI-Public: 00763000246723
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6068093
• Device Catalogue Number: 6068093
• Device Lot Number: 1021479W
• 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: 09/17/2024
• Initial Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 05/17/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White