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

Model Number	G7540020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Intervertebral Disc Compression or Protrusion (4524); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: g 7540020, serial/lot #: (b)(4), ubd: 28-nov-2016, udi#: (b)(4); product id: g7540020, serial/lot #: (b)(4), ubd: 14-nov-2016, udi#: (b)(4); product id: g7540020, serial/lot #: (b)(4), ubd: 14-nov-2016, udi#: (b)(4); product id: g7540020, serial/lot #: (b)(4), ubd: 14-nov-2016, udi#: (b)(4); product id: g75446540, serial/lot #: (b)(4), ubd: 28-jul-2016, udi#: (b)(4); product id: g75446540, serial/lot #: (b)(4), ubd: 30-jun-2016, udi#: (b)(4); product id: g75447540, serial/lot #: (b)(4), ubd: 28-jan-2017, udi#: (b)(4); product id: g75447540, serial/lot #: (b)(4), ubd: 14-jan-2017, udi#: (b)(4); product id: g75447545, serial/lot #: (b)(4), ubd: 14-sep-2016, udi#: (b)(4); product id: g75447545, serial/lot #: (b)(4), ubd: 14-oct-2016, udi#: (b)(4); product id: g75447545, serial/lot #: (b)(4), ubd: 12-jun-2016, udi#: (b)(4); product id: g8115545, serial/lot #: (b)(4), ubd: 07-aug-2016, udi#: (b)(4); product id: g8115558, serial/lot #: (b)(4), ubd: 07-aug-2016; product id: g869h021, serial/lot #: (b)(4), ubd: 02-sep-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via manufacturer representative regarding a patient with lumbar degenerative spondylolisthesis for plif.It was reported that there were patient symptoms or complications as a result of this event.Details were unknown.Re-operation was scheduled for (b)(6) 2021.Additional information received from manufacturer representative that the patient complications as a result of this event was left lower limb paralysis due to lumbar disc herniation at l1 / 2.There were no malfunctions with the products implanted in the past.Additional surgery performed as a result of this event for hernia removal on (b)(6) 2021 as scheduled.After removing the l1 / 2 hernia, set screws and rod that had been implanted in l2-5 in the past were removed (returned to the patient).Thoracic kyphosis correction was also performed.Ps was inserted into t11 / 12 / l1.While pulling up nesplon through l1, rods were tightened at t11-l5.Two prolock were placed and the procedure was completed.Monitoring of nuvasive company was used during the operation.Initially there was no left-side reaction, and after decompression, the left-side waveform was almost nonexistent, but the left-side waveform also appeared at the final stimulus just before the end of the operation.
Event or Problem Description
Medical safety assesses the reported event of ¿lumbar disc herniation¿ at the adjacent level as not related to the device.There were no malfunctions with the implanted product.The disc herniation occurred at the adjacent level.
Additional Manufacturer Narrative
Medical safety review: medical safety assesses the reported event of ¿lumbar disc herniation¿ at the adjacent level as not related to the device because of the following: there were no malfunctions with the implanted product.The old surgery was l2/5.However, the disc herniation occurred at the adjacent level (l1/2).Adjacent disc disease is a known scenario of degenerative disc disease (ddd) progression (saavedra-pozo et al., 2014).Moreover, the patient was a female at age 62, which makes her highly susceptible to osteoporosis (varst et al., 2018).Osteoporosis is known to expedite ddd progression (li et al., 2019).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
• MDR Report Key: 11567934
• Report Number: 1030489-2021-00404
• Device Sequence Number: 3622152
• Product Code: KWP
• UDI-Device Identifier: 00613994143181
• UDI-Public: 00613994143181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: G7540020
• Device Catalogue Number: G7540020
• Device Lot Number: H08K9025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 37