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 54740006535

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog#(b)(4) 510k# k091974, udi# (b)(4).Was cleared in the united states.Radiographic image review : ap oblique x-ray post op for l5-s1 interbody fusion.An interbody graft is present.One of the l5 screw does not have the rod through the tulip head but the setscrew is still on the tulip.Fusion status is unknown.This review was conducted by hcp.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with unknown indi cation.It was reported that revision surgery was planned on (b)(6) 2021 due to slipping out of rod.The rod was slipping out from the head of the left l5 ps.At the same time, a clear zone was recognized on the ct image of looseness on the right ps of s1.It was unknown whether the device was broken or not.Patient felt uncomfortable while changing tires in (b)(6) 2020, and after that, low back pain and posterior thigh and breech pain appeared, and it was thought that the rod backed out at this time.There was health damage on the patient.It seemed that the symptoms were due to that the implant backed out and bone fusion was not achieved or breakdown, so screw replacement was scheduled.Initial surgery was performed on (b)(6) 2017.The type and level of initial surgery procedure or technique performed were l5 spondylolytic spondylolisthesis, plif (combined with capstonepeek) between l5 / s1 and ps fixation with solera47.Product used correctly according to the directions given in the ifu/labeling.Additional information received on (b)(6) 2021 states that the rod on the left side of the screw(l5) on the head side backed out from the screw.When the responsible person checked the product, there were slip marks on the crimped part of the rod and set screw.In the opinion of the person in charge, the rod length should be set to a relatively proper length by doctor, and maybe the selected rod was short and fixed at the rod end.In reoperation on (b)(6) 2021, all the implant products were removed, and replacement was performed.No further complications were reported.

Manufacturer Narrative

Part#: 54740006535, lot#: h5100720.Visual and optical inspection revealed, some damage to the female torx.And the threads in the head of the screw.The crown of the screw has been worn and deformed from the seating of the rod.The screw head was locked in a slightly angled position and was not able to pivot in any direction.The crown has been pushed down through the saddle of the screw not allowing the head to pivot anymore.Functional inspection with sample set screw confirmed, the screw was able to be threaded into the head of the bone screw without any issue.The screw appears to function as intended.Unable to determine, root cause of issue.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 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: 11312649
• MDR Text Key: 231644488
• Report Number: 1030489-2021-00180
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 08/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: 54740006535
• Device Catalogue Number: 54740006535
• Device Lot Number: H5100720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 08/07/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 66