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

Model Number	55850016550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient previously implanted with screws in a percutaneous psf at t10-l2.It was reported that the screws malfunctioned sometime between implant and removal, likely during one of the patient's falls.Upon explantation, the hcp noticed that the screws tulips were welded to the shank in a way that the poly axial range of motion was lost and the tulip was ¿fixated¿ at a different degree for each of the respective screws.The surgeon was unable to put the shank of the driver through the tulip to seat it inside of the screw shank because the fixated tulip was blocking a straight path way for the driver to seat.The malfunctioning of the screws was likely due to a fall.The patient is osteoporotic and the screws were haloing severely and loose.The patient has had multiple falls.The hcp determined that the screws did not stabilize the patient as he had hoped.The surgeon decided to remove hardware as part of her preventative treatment plan and at the time of the hardware removal, he noticed the screw malfunction.There is no injury to the patient due to the screw malfunction.The date of implant was (b)(6) 2022 and the date of explant was on (b)(6) 2022 for the reported screws.The patient's medical history includes t12 fracture - trauma.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part# 55850016550 ; lot# h5606889- visual and optical inspection revealed that the top portion of the crown of the screw has been worn from the seating of the rod.Functional inspection confirmed that the screw head was locked in an angled position and was not able to pivot in any direction.The crown has been pushed down through the saddle of the screw not allowing the head to pivot anymore.This is the normal issue when the bone screw is implanted.The screw appears to function as intended and there was no fault found.H6: updated eval.Code method, eval.Code result, and eval.Code conclusion post analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14913674
• Report Number: 1030489-2022-00612
• Device Sequence Number: 17686209
• Product Code: NKB
• UDI-Device Identifier: 00643169768284
• UDI-Public: 00643169768284
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 55850016550
• Device Catalogue Number: 55850016550
• Device Lot Number: H5606889
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2020
• 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 Age: 83 YR
• Patient Sex: Female