MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5599130
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op of reported product.It was reported that, there were issues with the modulex drivers and tulip inserters (old and new).Modulex locking drivers lock up in a position where they will not open or close at all, completely stuck so cannot open up to load screw and then cannot drive down to lock onto screw.Tulip inserters somehow the inserter was prematurely converting the tulip from open to locked mode (so it won't pop onto the screw post).Also, not engaging tulip properly - need to flush with saline or debride of tissue, sometimes still won't load tulip, so opened a new tulip and it it'll connect perfectly.The failure of reported items added excess time to the procedure.There was no information made available on the patient involvement, no further complications reported.There were no patient symptoms reported, no additional treatment or surgery performed as result.No further complications reported.
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.
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
Additional information received from manufacturer representative states, procedure or technique performed was laminectomy/decompress ion/transforaminal lumbar interbody fusion.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19256475
• Report Number: 1030489-2024-00408
• Device Sequence Number: 14095575
• Product Code: LXH
• UDI-Device Identifier: 00763000583750
• UDI-Public: 00763000583750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 5599130
• Device Catalogue Number: 5599130
• Device Lot Number: K22M1290
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 08/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown