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

Model Number G9010001550

Device Problems Material Deformation (2976); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- lumbar spinal canal stenosis involved in the reported event.Levels implanted- l4-s1.It was reported that event was an operation to perform 5/s1 plif to extend due to adjacent segment disease of the fusion at l4/5 performed more than 10 years ago.L4-s1 fusion.It seemed that one side of the screws on both sides (gold) stripped when attaching the crosslink.Therefore, opened the product with a different part number and used the screws (gold) on both sides.There was delay in overall procedure time for less than 60 minutes.Event was revision surgery.No health damage in the patient was reported.On 2021-dec-24, received additional information that the set screw on one side stripped when the reported crosslink (g9010001550) was finally tightened.Therefore, another crosslink (size of 40) was opened and replaced the stripped set screw only.It is unknown whether the counter was used at the time of tightening.On 2022-jan-11, received additional information that therapy was plif of 5/s1, l4-s1 posterior fusion.M8 was used for the initial surgery.It was reported that adjacent segment disease to be unrelated to the products used in the initial surgery.Adjacent segment disease occurred at 5/s.All the products used in the initial surgery were removed, these products were implanted more than 10 years ago, and products were d iscarded by the facility.

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 Description

Information was received from healthcare professional via field representative regarding patient with pre-op diagnosis- lumbar spinal canal stenosis involved in the reported event.Levels implanted- l4-s1.It was reported that event was an operation to perform 5/s1 plif to extend due to adjacent segment disease of the fusion at l4/5 performed more than 10 years ago.L4-s1 fusion.It seemed that one side of the screws on both sides (gold) stripped when attaching the crosslink.Therefore, opened the product with a different part number and used the screws (gold) on both sides.There was delay in overall procedure time for less than 60 minutes.Event was revision surgery.No health damage in the patient was reported.On 2021-dec-24, received additional information that the set screw on one side stripped when the reported crosslink (g9010001550) was finally tightened.Therefore, another crosslink (size of 40) was opened and replaced the stripped set screw only.It is unknown whether the counter was used at the time of tightening.On 2022-jan-11, received additional information that therapy was plif of 5/s1, l4-s1 posterior fusion.M8 was used for the initial surgery.It was reported that adjacent segment disease to be unrelated to the products used in the initial surgery.Adjacent segment disease occurred at 5/s.All the products used in the initial surgery were removed, these products were implanted more than 10 years ago, and products were d iscarded by the facility.On 2022-feb-03, received additional information that both set screws had scratched hex holes.Threads were also scratched.

Manufacturer Narrative

Additional information- b5, h6.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.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.

Manufacturer Narrative

H3: product analysis of part#g9010001550 ; lot# h5712915 analysis summary: after visual and optical examination and functional testing, it does not appear to be any functional issues with the screw.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® SPINAL SYSTEM
• Type of Device: 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: 13288050
• MDR Text Key: 288819832
• Report Number: 1030489-2022-00055
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G9010001550
• Device Catalogue Number: G9010001550
• Device Lot Number: H5712915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1