MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840006550
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: product id# 55840006550; lot# h5124856 visual examination of the mas bone screws "tulip" has been separated from the bone screw at approximately the base of the bone screw head.The damage on the sphere of the bone screw appears to show it may have exceeded the acceptable angle of the screw.Visual and optical inspection of the "tulip" identify that the c-clip has been damaged.After visual, optical, and microscopic examination, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The damage 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.
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a screw used in l5-s2 tlif & posterior fusion for mis posterior repeat decompression and revision instrumentation fusion at l5-s1.Levels implanted: l5-s1.It was reported that after the rods were removed, one screw tulip was stuck in a very awkward position.Due to the angle, the doctor had difficulties getting his driver into the screw head.He used a counter torque to move the tulip, and applied a significant amount of force.After removing the counter torque, it was noted that the tulip had come off the screw shank.The shank was able to be removed without incident.The tulip/shank do not appear to be broken, just separated from each other.Patient symptoms are unknown.No further complications were reported/anticipated.Additional information was received.It was reported that there were no patient symptoms.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 19699765
• Report Number: 1030489-2024-00796
• Device Sequence Number: 18086669
• Product Code: KWP
• UDI-Device Identifier: 00613994971760
• UDI-Public: 00613994971760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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: 55840006550
• Device Catalogue Number: 55840006550
• Device Lot Number: H5124856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2014
• 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
• Patient Sex: Unknown