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

Model Number	7576545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, other) regarding a patient having spinal therapy for l4-l5 degenerative disc and fixation.It was reported that right side was pathology side, l4,l5 all 4 guidewires were placed.Right side decompression was done via metrx tube and capstone cage placed.Screws and sextant rod were placed on right side.Left side screws were placed, when surgeon mated the towers, he felt one of the towers was loose , so he took a shot to find out that tower along with tulip of screws is disengaged from the screw shaft the screw shaft was in l5 body on left side he removed the tower, with help of guidewire and removal driver removed the screw shaft from l5 body it was replaced with new screw, towers were mated and sextant rod was inserted, bop's placed and break off done.  there was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received form manufacturer that screw shaft broken from its tulip during surgery.
Additional Manufacturer Narrative
H3: product analysis:product id (b)(4) ; lot# h5794410 visual inspection confirmed the mas screw was returned with the bone screw shank separated from the pedicle head.Macroscopic inspection revealed the multi axial ring has been damaged also due to the bone screw shank pulling loose.The separation appears to be from overload as the root cause.The internal testing shows a load of 3100n -5400n (tr12-249) depending on lmc/mmc to separate the head assembly from the shank.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): 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19189003
• Report Number: 1030489-2024-00341
• Device Sequence Number: 12835817
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 7576545
• Device Catalogue Number: 7576545
• Device Lot Number: H5794410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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