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

Model Number	6061000
Medical Device Problem Codes	Device Slipped (1584); Mechanical Jam (2983)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient with unknown indication for spinal therapy.It was reported that when using the catalyft pl device on a case and after the device had been implanted and was being backfilled with autograph bone via the funnel (that screws into the inserter) became jammed.It was skived off and the aggressive distal point caused a dura injury to the patient.Additional information received from manufacturer representative that the pre-op diagnosis was lumbar stenosis and the procedure involved was posterior lumbar interbody fusion.Product came in contact with the patient.After implantation of the implant, per the surgical technique, the surgeon removed the inner portion of the inserter, screwed on the bone funnel portion and began to plunge the autogenous bone graft through the inserter with the graft tamp.While plunging the bone, the inserter slips off of the implant and he says it tore the dura.There was an additional medical intervention done as a result of this.Surgeon sutured the dura for repair, and applied a dura sealant.Additional information received from manufacturer representative that the inserter hasn¿t been returned because there is no defect in it.

• 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
• MDR Report Key: 12323757
• Report Number: 1030489-2021-01052
• Device Sequence Number: 17321565
• Product Code: MAX
• UDI-Device Identifier: 00763000253530
• UDI-Public: 00763000253530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: 6061000
• Device Catalogue Number: 6061000
• Device Lot Number: KH21C252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention