MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	9010000849
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the health care professional via a manufacturer representative regarding a device used in percutaneous posterior screw fixation therapy for back pain, sciatica.Levels implanted were l5-s1.It was reported that upon implanting the percutaneous rod on the patient¿s left side, there was a snapping noise.Upon hearing the noise, the surgeon pulled the inserter out of the wound and realized the rod had released from the inserter.Rod was then fished out with a kocher.Attempted to re-engage rod with inserter but the inserter was not working properly and would not engage rod any longer.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis #(b)(4), product #9010000849, lot #k22k1121 visual and functional inspection the inner shaft does not move when the locking lever is moved.The "c" clip that connects the adjusting mechanism to the shaft appears to have come out.The inner shaft has become unthreaded and will no longer thread back in.It is possible to overload the clip if making tension adjustments while the rod is in place.It appears that the clip may have been overloaded.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: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 21705037
• Report Number: 1030489-2025-01552
• Device Sequence Number: 21317630
• Product Code: KWP
• UDI-Device Identifier: 00643169537736
• UDI-Public: 00643169537736
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132639
• 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): 03/27/2025

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: 9010000849
• Device Catalogue Number: 9010000849
• Device Lot Number: K22K1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male