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

Model Number 54840005545

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Country: (b)(6).Radiographic image review: post-op x-rays for l4-5 fusion posterior approach provided.There is a grade i-ii l4-5 spondylolisthesis.The instrumentation appear undersized and on one side medially placed.One of the l5 screws broken.No interbody graft is used.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via manufacturer representative regarding a patient with an indication of back pain with radiculopathy and l4-l5 spondylolisthesis in need of l4-l5 stabilization and laminectomy used in spinal therapy.It was reported that the screw has broken that was implanted on (b)(6) 2019 and patient instability with back pain.The broken screw was removed and implanted a bigger one.There was no fusion after one year. there were no fragments in the patient reported.The patient issue has been resolved after second surgery.There were no further complications reported regarding the event.

Manufacturer Narrative

Additional information: d9, h3, h6 h6.Device evaluation summary: visual examination revealed the screw was broken about 4 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.Major fracture surface smearing is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with progressive striations consistent with cyclic fatigue.The threads of the broken lower portion of the screw have been damaged, possibly from the removal process.This type of damage is consistent with cyclic fatigue followed by overload once the fatigue had weakened the material.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: 11017295
• MDR Text Key: 221749038
• Report Number: 1030489-2020-01797
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00613994589743
• UDI-Public: 00613994589743
• Combination Product (y/n): N
• PMA/PMN Number: K091974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54840005545
• Device Catalogue Number: 54840005545
• Device Lot Number: H5561531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 85