MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	5011222
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during use of the reported products.The pre-op diagnosis was mentioned as l4 / 5 cage movement.It was reported that, l4 / 5plif fusion in the case of re-decompression was performed on (b)(6) 2021.L4/l5 cage movement was seen during follow-up.There was looseness of screw also reported.The l4/l5 screw was removed, and screws were placed again into l3/4/5/s.Cage was inserted again during re-operation.Revision surgery was performed on (b)(6)2022 and the cages were re-inserted.The looseness of screw was identified during the revision surgery.The cages were implanted and remains in service and the screws, rod were explanted ¿ complete.There were no patient symptoms reported as a result of this event.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during use of the reported products.The pre-op diagnosis was mentioned as l4 / 5 cage movement.It was reported that, l4 / 5plif fusion in the case of re-decompression was performed on (b)(6) 2021.L4/l5 cage movement was seen during follow-up.There was looseness of screw also reported.The l4/l5 screw was removed, and screws were placed again into l3/4/5/s.Cage was inserted again during re-operation.Revision surgery was performed on (b)(6) 2022 and the cages were re-inserted.The looseness of screw was identified during the revision surgery.The cages were implanted and remains in service and the screws, rod were explanted ¿ complete.There were no patient symptoms reported as a result of this event.No further complications reported.
Additional Manufacturer Narrative
Radiographic image review result: post op mri/ct axial slice lateral x-ray sagittal ct single slice post revision/extension of fusion lateral x-ray.Comparison x-ray at l4-5 show apparent cage back out.Time difference between x-ray is unknown.There is a possibility of bone in the interbody space.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: CAPSTONE CONTROL PTC¿ SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 13522679
• Report Number: 1030489-2022-00149
• Device Sequence Number: 5298911
• Product Code: MAX
• UDI-Device Identifier: 00643169677524
• UDI-Public: 00643169677524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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 Expiration Date: 01/15/2026
• Device Model Number: 5011222
• Device Catalogue Number: 5011222
• Device Lot Number: H5393953
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/20/2022
• Date Device Manufactured: 01/15/2018
• 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: 85 YR
• Patient Sex: Male