MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840007545
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider, clinical study via manufacturer representative regarding a patient with clinical id: (b)(6) and study id: (b6).Medical history (positive response): surgery 1: date of surgery: (b)(6) 2016 type of spinal surgery: discectomy level(s): l4/l5 details: microdiscectomy surgery 2: date of surgery: (b)(6) 2016 type of spinal surgery: other level(s): l4/l5 details: medial facetectomy surgery 3: date of surgery: (b)(6) 2016 type of spinal surgery: foraminotomy level(s): l4/l5 details: foraminotomy for recurrent herniated disc surgery 4: date of surgery: (b)(6) 2016 type of spinal surgery: discectomy level(s): l4/l5 details: revision of microdiscectomy surgery 5: date of surgery: (b)(6) 2016 type of spinal surgery: other level(s): l4/l5 details: revision of medial facetectomy surgery 6: date of surgery: (b)(6) 2016 type of spinal surgery: foraminotomy level(s): l4/l5 details: revision.Describe the additional surgical procedure: revision of left l5 screw.Levels involved in additional surgical procedure: l5/s1 specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: related plf grafting material related to surgical construct and/or surgical procedure: not related posterior fixation related to surgical construct and/or surgical procedure: causal relationship interbody fusion related to surgical construct and/or surgical procedure: not related surgical procedure related to surgical construct and/or surgical procedure: causal relationship primary diagnosis: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis).The number of consecutive levels (from l2- s1) the subject will have treated: 2 lev.Breach of left l5 pedicle screw.Patient reported left leg and left gluteal pain immediately post-op.Patient was returned to or for revision of left l5 pedicle screw left leg and left gluteal pain improved after revision.Randomization assignment: 12mg of rhbmp-2 randomization date: (b)(6) 2022 number of levels to be treated: 2 levels onset date (b)(6) 2022 interventions: surgical intervention & other relevant actions outcome status: resolved.Sponsor assessed causal relationship to post.Fixation/surgical procedure.Not related to plf grafting/ interbody fusion.
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.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.
Event or Problem Description
B5: mdr decision corrected to not reportable.No additional supplemental reports will be required unless additional information received indicates reportable event.
Additional Manufacturer Narrative
H10: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunction.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.B5.Event description updated.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
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 15415853
• Report Number: 1030489-2022-00857
• Device Sequence Number: 14149595
• Product Code: KWP
• UDI-Device Identifier: 00643169004344
• UDI-Public: 00643169004344
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 01/31/2025
• Device Model Number: 55840007545
• Device Catalogue Number: 55840007545
• Device Lot Number: UNKNOWN
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/19/2022
• Date Device Manufactured: 04/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White