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

Model Number 54740006545

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #: 54840006545, 510k, #: k091974, and udi (b)(4) was cleared in the united state.Radiographic image result: post-op x-ray for l4-s1 posterior spinal interpretation.Pedicle screw at l4 to s1 are seen, an interbody graft is present at l4-s1.There appears to be screw loose present in the interbody space.Both of the s1 screws appear fractured.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 l5 spondylolytic spondylolisthesis involved in l4-s(l5/s:plif) procedure used in spinal therapy.Levels implanted - l4 to s1ps.It was reported that during use, the screws of ps on both sides of s1 broke.The delay in overall procedure was less than 60 minutes.Additional surgery was performed to remove the broken screw.Revision surgery was performed to remove broken screw as patient felt back pain.It was reported they tried to remove the broken screw with pse1, but the removing was given up because the spinal canal was near and it would defeat the purpose if the nerve root is damaged.Device status reason : explanted-partial initial surgery - plif was performed at l5/s due to l5 spondylolytic spondylolisthesis.Ps was used at l4 since the pedicle of l5 was thin due to l5 pedicle aplasia and ps was difficult.On (b)(6) 2020, received additional information that product that was collected after revision surgery will be returned.There was no pain reported after the re-operation.

Manufacturer Narrative

G4: this part is not approved for use in the united states; however a like device catalog # 54840006545, 510k #k091974 and udi #(b)(4) was cleared in the united state.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.

Manufacturer Narrative

Dvice evaluated summary- visual examination revealed the screw was broken about 7 threads down from the base of the bone screw head.Optical examination of the area of fracture initiation did not identify a pre-existing surface defect that could contribute to crack propagation.Some fracture surface smearing is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with progressive striations consistent with cyclic fatigue.This type of damage is consistent with cyclic fatigue followed by overload once the fatigue had weakened the material.Additional information: d9, g3, h3, 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.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: 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: 10910413
• MDR Text Key: 221291688
• Report Number: 1030489-2020-01699
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE 10
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54740006545
• Device Catalogue Number: 54740006545
• Device Lot Number: H5395042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 04/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 67