MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CATALYFT PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	6061002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
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 for lumbar 3-5 spondy and stenosis.It was reported that during a transforaminal lumbar interbody fusion (tlif) procedure for lumbar 3-5 spondylolisthesis and stenosis, several issues occurred with the surgical instruments.The tip of the catalyft driver broke while expanding the implant, and although the tip was retrieved, it was discarded on the field and not recovered.Additionally, the nav tap cold welded into one of the nav locks, and it was discovered that the tap itself was bent, although other instruments were able to be used with the nav lock without issues.The trim line blades were also damaged, showing several markings and scruffs from high-speed burrs.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
H3: product analysis: part # 6061002; lot # k23d1368 visual inspection confirmed the tip of the catalyft inserter has broken.Optical inspection revealed a flat fracture surface with circular material flow.The damage to the instrument is consistent with overload.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): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21352935
• Report Number: 1030489-2025-00680
• Device Sequence Number: 18421039
• Product Code: MAX
• UDI-Device Identifier: 00763000253554
• UDI-Public: 00763000253554
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 05/04/2025

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: 6061002
• Device Catalogue Number: 6061002
• Device Lot Number: K23D1368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Unknown