MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA 4.75; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_SCRW_SOLR

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Inflammation (1932); 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 provider (hcp) via a manufacturer representative regarding a patient who was implanted with a spinal product type for lumbar spinal canal stenosis.It was reported¿¿that l4 / 5 olif was performed in the initial operation on (b)(6) 2014.On (b)(6) 2020, re-operation was performed due to adjacent segment disease.Bone fusion between l4 / 5 was achieved, l3 / 4 plif, l2 / 3 decompression and l3 / 4 fixation were performed.The cages at this time backed out and bone fusion had not been achieved.Re-operation was scheduled for 3/12.Cage implanted and remains in service.It was unknown whether the device was broken or not.Re-operation was scheduled for 3/12 was the patient symptom/complications associated with this event.No further complications were reported.It was reported that there was numbness from the right buttock to the thigh.Postoperative leg movement is good, and improvement in numbness is unknown.In l3 / 4 plif, lateral slip occurred, which seemed to be compressing the spinal cord.There was a comment that the suspected infection cannot be ruled out as the cause, and the intervertebral disc might be inflamed during the operation.All screws and rod were removed from posterior side.Solera475.The screw of l3 was loose and the cage was not bone-fused.Part of the surrounding bone was stuck, dissociation was performed from the posterior side, and two rt were removed by olif approach.Autologous bone from ilium bone was placed between the vertebralbodies.From the posterior side, screws were inserted into l345 with solera 5560 cbt, rod was placed, and the procedure was completed.Patient medical history: (b)(6).It was reported that the information in mpxr report is incorrect.Patient surname (b)(6), first name (b)(6), male, this is the correct information.

Manufacturer Narrative

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

Additional information received that there was no malfunction with the rod and it had no relation with symptoms.The product id and lot# of the screw is unknown.

• Brand Name: CD HORIZON SOLERA 4.75
• 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: 11733214
• MDR Text Key: 252932108
• Report Number: 1030489-2021-00538
• 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
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_SOLR
• Device Catalogue Number: MSB_UNK_SCRW_SOLR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention