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

Model Number	6541101
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: other relevant device(s) are: product id: 6541101, serial/lot #: (b)(6), ubd: 21-sep-2027, udi #: (b)(4), 510(k): k201362.Product id: 55750017545, serial/lot #: (b)(6), ubd: 14-mar-2031, udi #: (b)(4), 510(k): k170679.Product id: 55750017545, serial/lot #: (b)(6), ubd: 26-jul-2031, udi #: (b)(4), 510(k): k170679.Product id: 7078396, serial/lot #: (b)(6), ubd: 06-dec-2031, udi #: (b)(4), 510(k): k202328.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 healthcare provider (hcp) via a manufacturer representative regarding a patient having plif for spinal canal stenosis.It was reported that set screws dislodged and replacement surgery occurred. the screws were loose and replaced.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Additional information: d10: product id: 7078396, serial/lot #: (b)(6) (quantity: 2) was not a defective product.Radiographic image review: ap lumbar interbody fusion, one of the set screws on the superior level is out of the screw tulip lateral view of 1, the construct appears intact.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
H3.Product analysis product id :6541101, lot no: h5792406 visual and optical examination revealed that there were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.Functional evaluation of the returned implant with a sample bone screw confirmed the set screw was able to engage and thread into the head of the bone screw without issue.The bottom node of the set screw shows signs of off axis/ uneven wear from the seating of the rod.There is some smearing / damaged to the nodes and the screw saddles from what appears to be the rods moving between the saddles and set screw.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
H3.Product id : 6541101, lot no.: h5792410.Visual and optical examination revealed that there were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.Functional evaluation of the returned implant with a sample bone screw confirmed the set screw was able to engage and thread into the head of the bone screw without issue.The bottom node of the set screw shows signs of off axis/ uneven wear from the seating of the rod.There is some smearing/damaged to the nodes and the screw saddles from what appears to be the rods moving between the saddles and set screw.Product id : 55750017545 lot no.: h5841874 visual and optical examination revealed that there were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.Functional evaluation of the returned implant with a sample bone screw confirmed the set screw was able to engage and thread into the head of the bone screw without issue.The bottom node of the set screw shows signs of off axis/ uneven wear from the seating of the rod.There is some smearing/damaged to the nodes and the screw saddles from what appears to be the rods moving between the saddles and set screw.Product id : 55750017545 lot no.: h5878308 visual and optical examination revealed that there were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.Functional evaluation of the returned implant with a sample bone screw confirmed the set screw was able to engage and thread into the head of the bone screw without issue.The bottom node of the set screw shows signs of off axis/ uneven wear from the seating of the rod.There is some smearing/damaged to the nodes and the screw saddles from what appears to be the rods moving between the saddles and set screw.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 SOLERA VOYAGER SPINAL SYSTEM
• 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: 19402430
• Report Number: 1030489-2024-00580
• Device Sequence Number: 17879044
• Product Code: NKB
• UDI-Device Identifier: 00763000211196
• UDI-Public: 00763000211196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 6541101
• Device Catalogue Number: 6541101
• Device Lot Number: H5792406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 07/12/2024; 07/12/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 06/20/2024; 07/24/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown