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

Model Number 55840007550

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Pain (1994)

Event Date 08/08/2022

Event Type  Injury  

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.

Event Description

Information was received from healthcare provider, clinical study via manufacturer representative regarding a patient with clinical id: (b)(6) and study id: (b)(6).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 hern iated 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 c onsecutive 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: 2022-07-27 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.Removed set screws- item #5540300 new set screws- item #5540030.

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.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: 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: 15630496
• MDR Text Key: 301990075
• Report Number: 1030489-2022-00966
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169004351
• UDI-Public: 00643169004351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 55840007550
• Device Catalogue Number: 55840007550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 11/08/2022
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White