MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	6068073
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with spacer having spinal therapy for rod fracture.It was reported that bone fusion had not occurred because the cage shifted immediately after the surgery.It is unknown whether the issue is due to the jack-down of cy or the absence of screw insertion into s, and the lack of compression at l5-il, but it was backing out.Since re-fixation is required, the hospitalization would be extended by approximately one month.Revision surgery was performed to explant the cage.The explanted cage had no damage and jack-up could be done.Levels implanted for the migrated cage was l5/s.1 cage was also inserted into l2/3, the 2 cages were used for l5/s.One of the two placed at 5/s, one backed out.The one placed at l2/3 jack-downed.Both were removed, and autologous iliac bone grafting was performed.The other one at 5/s has no issues and remains in place.This event was a repeat surgery and no medtronic product involved in initial surgery.There were no further complications reported regarding the event.
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.
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.

• Brand Name: CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23081882
• Report Number: 2647346-2025-00105
• Device Sequence Number: 11958660
• Product Code: MAX
• UDI-Device Identifier: 00763000246693
• UDI-Public: (01)00763000246693(17)321212(10)1048882W
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 6068073
• Device Catalogue Number: 6068073
• Device Lot Number: 1048882W
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown