MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	25740011090
Medical Device Problem Codes	Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider via a manufacturer representative regarding a patient who was implanted with a spinal product type for proximal junctional kyphosis.It was reported that set screws on both sides of s2ai backed out after the operation.Both were completely backed out from the screw head.At the moment, follow-up was scheduled, and the schedule for reoperation was undecided.The patient could not run or walk due to sudden numbness.X-ray findings revealed that the left and right s2ai set screws had came off.It was revision surgery.In the initial operation on (b)(6) 2016, fixed to t10-l4 with l1 vertebral column resection(vcr) due to l 1 fracture.In the second operation on (b)(6) 2019,extension of fixing due to broken rod or something.Extended to t10-s2ai.Reinforcement using domino and cover for broken part of rod.In the third operation ((b)(6) 2019), only the ba set screw that was inserted into s2ai on the right came off (disengaged), so it was expanded with surgical precision and the set screw was replaced.The breakoff had also been completed without any problems.In the fourth operation ((b)(6) 2020).Reinforcement operation for rod replacement and additional intervertebral fusion due to rod breakage.At this time, the ba set screw inserted into the s2ai on the right had also came off.Since rod was replaced, the set screw had also been changed to a new one.In the fifth operation ((b)(6) 2021) pjk occurred, the rod must had been broken, so rod was replaced, and reinforcement operations such as fixed extension to t7 were performed.The s2ai screw was also replaced and various set screws were also replaced with new ones.On (b)(6) 2021, the patient could not run or walk due to sudden numbness.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: product analysis #(b)(6):25740011090 lot# ca15k164 visual and microscopic inspection confirmed the set screw has some deformation on the node of the screws.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.The threads of the set screws have been damaged.Functionally tested with a bone screw and confirmed the screw would still thread into the head of the bone screw.Without the rods that was used in the procedure, no root cause could be determined.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® BALLAST¿ SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 11805115
• Report Number: 1030489-2021-00599
• Device Sequence Number: 3832117
• Product Code: NKB
• UDI-Device Identifier: 00643169415126
• UDI-Public: 00643169415126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153442
• 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,Followup
• Report Date (Section B): 04/19/2022

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 Expiration Date: 03/08/2024
• Device Model Number: 25740011090
• Device Catalogue Number: 25740011090
• Device Lot Number: CA15K164
• 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: 04/15/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 03/30/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 01/18/2022; 04/19/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown