MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	559200028
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having idiopathic scoliosis case-open manipulation for idiopathic scoliosis.It was reported that it was noticed in the 1 year follow up x ray, that the set screws have come off the distal heads of 3-4 distal screws at l2/l3 levels.The revision surgery is scheduled for 7/19/25.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
D1, d4, g4: product identifiers are unknown.G4: 510(k) is unknown.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.
Additional Manufacturer Narrative
Additional information: b5.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
Additional information was received from the manufacturer representative stating that the revision surgery is scheduled for (b)(6) 2025, and he can't provide any further information until then.
Event or Problem Description
Additional information was received from the manufacturer representative stating that 5 set screws were explanted in the revision surgery and are available for return.
Additional Manufacturer Narrative
B5: additional information has been updated.D4: product identifiers have been updated along with unique identifier (udi).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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: UNKNOWN
• Common Device Name: 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22325193
• Report Number: 1030489-2025-02319
• Device Sequence Number: 8924111
• Product Code: KWP
• UDI-Device Identifier: 00763000608217
• UDI-Public: (01)00763000608217(17)271030(10)H5807529
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 559200028
• Device Catalogue Number: 559200028
• Device Lot Number: H5807529
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/25/2025; 08/26/2025
• Date Device Manufactured: 10/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male