MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX® RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	6958714
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: report reference number- (b)(4).H6 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 multiple sources (manufacturer representative, healthcare provider, regulatory body) regarding a patie nt implanted with screw having spinal therapy for cervical spondylotic myelopathy.It was reported that the patient underwent posterior cervical incision, decompression, bone grafting, fusion and internal fixation under general anesthesia, and screws were used during the operation on (b)(6) 2024.During the stay in the hospital, the wound was normal and the patient was discharged without removing the stitches. medication was not followed properly by patient and did not monitor blood sugar after discharge. on (b)(6) 2024, the patient was hospitalized again due to postoperative wound infection of the cervical spine. patient underwent debridement, perfusion and drainage for cervical spine postoperative infection and the patient was discharged after healing. event occurred due to patient's own reasons.Loosening of internal fixation was reported.There were no further complications reported regarding the event.Additional information received that post-operative infection occurred was not related due to reported screw.

• Brand Name: VERTEX® RECONSTRUCTION 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: 19738724
• Report Number: 1030489-2024-00818
• Device Sequence Number: 14356581
• Product Code: KWP
• UDI-Device Identifier: 00613994355041
• UDI-Public: 00613994355041
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/15/2024

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: 6958714
• Device Catalogue Number: 6958714
• Device Lot Number: H5817971
• 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: 06/19/2024
• Initial Report FDA Received Date: 07/15/2024
• Date Device Manufactured: 12/19/2022
• 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 Age: 65 YR
• Patient Sex: Male