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

Model Number 54750017545

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Numbness (2415)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during use in patient who underwent an initial tlif surgery at one intervertebral disc on l5/s1 on (b)(6) 2020 for the diagnosis of spondylolisthesis.It was reported that the cage backed out which caused pain in the legs and numbness for the patient and the screws loosened.The patient underwent a revision surgery where the backed-out cage was removed and replaced with ev, the loose ps was removed, a thick screw of s4 was used and the fusion was extended to sai.There was a delay of less than 60 mins.Since.The time from the initial surgery to revision surgery operation was short and fusion was not complete.Post revision surgery, patient condition has improved, and no other injury / complication is reported.Product will not be returned since the customer discarded it, and it was replaced with a medtronic product.

Manufacturer Narrative

D6 a,b: implant and explant date were updated.H6: method code was updated since the device is discarded and will not be returned for analysis.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 SOLERA VOYAGER 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: 11330917
• MDR Text Key: 232559991
• Report Number: 1030489-2021-00201
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K143375
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54750017545
• Device Catalogue Number: 54750017545
• Device Lot Number: H5554199
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65