MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 6541104

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Post Operative Wound Infection (2446)

Event Date 02/27/2024

Event Type  Injury  

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 Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient had olif (l2/3/4) and t10~sai fixation and l5/splif from the rear.It was reported that the loose screw caused infection in patient.Although fixation was performed from t10 to sai, a wound appeared on the skin of the right sai area and pus also came out.When it was deployed, the tissue from the skin surface to the screw head continued to have dark granulation, and there was pus in the surrounding area.The set screw in the screw head was loose enough that it could be removed with forceps, and the surrounding tissue showed dark spots and black powdery matter.The screw that had been inserted had a clear zone on the image, but it was reasonably effective.The right side was in a noticeable condition, but when checked the left side, it was in the same condition.A revision surgery was performed due to suspicion of metallosis due to wear particles of the implant, black granulation on the soft tissues, wounds on the wound surface and pus in the vicinity.Implant was cut and removed.Initial surgery was done on (b)(6) 2023.Additional information received.The set screws were loose.There were no looseness or problem observed with the screw or prolock link.Additional information received.The rod installed in (passed through) the ballast closed is (b)(6)).This time, both set screws were loose.Therefore, it is considered that the rod went back and forth in the head of the ballast closed, and wear particles were released.Among the removed and recovered implant, there was a cut piece of a rod ((b)(6))) that was held in place to remove the ballast placed in sai.It is unclear why the set screw came loose.There may be evidence of metal scraping due to rubbing on the inside of the ballast closed head.There may also be signs of scuffing on the rod.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 18984840
• MDR Text Key: 338659813
• Report Number: 1030489-2024-00214
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 20763000211213
• UDI-Public: 20763000211213
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6541104
• Device Catalogue Number: 6541104
• Device Lot Number: H5786679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention