MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 54740016540

Device Problems Device Dislodged or Dislocated (2923); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Information was received from healthcare professional via field representative regarding patient with pre-operative diagnosis- reste nosis involved in the l3/4/5 screw removal l3/4/5 screw reinsertion, l3/4 tlif.Levels implanted- l3/4/5.It was reported that intra-operatively, the l3/4/5 screws were removed.An event occurred that the head of the screws inserted in the patient's body were locked diagonally and the screws could not be removed.Although the screws had be removed somehow, it was difficult.There was no health damage to the patient.Product was used correctly according to the directions given in the ifu/labeling.Patient was not hospitalized prolong as a result of this event.There were no patient symptoms reported.There were no further complications reported regarding the event.Mdt products used in initial surgery- solerase.Reported event is revision surgery.On 2022-jan-28, received additional information that revision surgery was performed due to screw loosening.There was no malfunction with mdt product- solerase used in the initial surgery.On 2022-feb-02, received additional information that the date of surgery when this event occurred is january 18th.On 2022-feb-03, received additional information that loosening occurred before this event.The looseness of the screw is the reason for this revision surgery.The event context is intra operative.The revision surgery was performed to remove and reinsert the same product.Event was not user error, it was usually removed normally, and the removed screw head itself was stiff, so it was recognized as a product problem.Screw that was loose remained at implanted level after initial surgery.The head of the screw inserted inside the patient was locked diagonally and the screw could not be removed."loose screw" was the process leading to the re-operation of this case.The implant date is unknown.

Manufacturer Narrative

This part is not approved for sale in the us but a similar part with catalogue# 54840016540 and 510k# k091974 and udi# (b)(4).Is approved for sale in the us.B1/b2/h1: model no- 54740016540 is not marketed in the us, but is similar to other marketed devices.Thus, it is reportable for malf unction, not serious injury, although surgical intervention did take place.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: product analysis: part #54740016540; lot #h5424960 visual and optical inspection revealed the top portion of the crown of the screw has been worn from the seating of the rod and the female torx has been damaged from the implant and removal process.Functional inspection confirmed the screw head was locked in an 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.This is a normal when the bone screw is implanted and removed.The screw appears to function as intended.No fault found.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: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13568934
• MDR Text Key: 289331707
• Report Number: 1030489-2022-00171
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54740016540
• Device Catalogue Number: 54740016540
• Device Lot Number: H5424960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female