MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_LONGITUDE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Numbness (2415)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturer representative regarding patient with radicular symptom of l5 involved in posterior lumbar interbody fusion (plif) procedure on l5-s1 used in spinal therapy.It was reported during use, four screws on l2, s1, il were loose and lower limb symptoms occurred on l5.All the screws were removed, ps were added on l1-s1-il, plif was performed on l5-s.Revision surgery was performed on (b)(6) 2019.On (b)(6) 2018, pf was performed on l2-s1 and plif was performed on l4-5.On (b)(6) 2019, additional fixation was performed with two screws on each left and right of il.There was no delay in overall procedure time.Levels implanted: l1-s1-il.Reported additional treatment and patient hospitalization or prolongation of existing hospitalization was necessary to perform plif additionally on l5-s1.Received updated information that patient developed neurological symptoms after the re-surgery on (b)(6) 2020.Screws that were explanted was discarded by the hospital.Health damage in the patient was reported.

Manufacturer Narrative

Correction: b2: intervention required was only check marked previously.In this correction report, check marked both hospitalization and intervention required in b2 section.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 Description

Information was received from healthcare professional via manufacturer representative regarding patient with radicular symptom of l5 involved in posterior lumbar interbody fusion (plif) procedure on l5-s1 used in spinal therapy.It was reported during use, four screws on l2, s1, il were loose and lower limb symptoms occurred on l5.All the screws were removed, ps were added on l1-s1-il, plif was performed on l5-s.Revision surgery was performed on (b)(6) 2019.On (b)(6) 2018, pf was performed on l2-s1 and plif was performed on l4-5.On (b)(6) 2019, additional fixation was performed with two screws on each left and right of il.There was no delay in overall procedure time.Levels implanted: l1-s1-il.Reported additional treatment and patient hospitalization or prolongation of existing hospitalization was necessary to perform plif additionally on l5-s1.Received updated information that patient developed neurological symptoms after the re-surgery on (b)(6) 2020.Screws that were explanted was discarded by the hospital.Health damage in the patient was reported.On (b)(6) 2020, received additional information that, products with loose screw were at both sides of l2, both sides of s1, two pieces at il.Looseness was confirmed on a total of 6 screws.Therefore, the products were replaced.Lower extremity pain occurred after reoperation, the l2 vertebral body slipped posteriorly, and reoperation was performed on (b)(6), 2020.On (b)(6) 2021, received additional information that probably pain, and numbness have been reported.It was unknown whether pain and numbness occurred at implant site.Patient status might be recovered.

Manufacturer Narrative

Additional information: b5, g3, h6.Fdp-c50672 and ime-e20 no longer applicable to this 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.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: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10581219
• MDR Text Key: 208417736
• Report Number: 1030489-2020-01340
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_LONGITUDE
• Device Catalogue Number: MSB_UNK_LONGITUDE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR