MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 6430530

Device Problem Mechanics Altered (2984)

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider via a manufacturer representative regarding a mas extender tab and set screw used for spinal therapy.Pre-operative diagnosis was lumbar spinal canal stenosis.Levels implanted was l4/5.Procedure performed was mis-tlif.It was reported that intra-operatively, the reported product was used with the l4 right pedicle screw.At the time of final tightening, the set screw did not break off and idled.Even though the set screw was replaced, it did not improve, so the reported product had been replaced.The final tightening could not be performed when fixing at one intervertebral disc with voyager 4.75.After the final tightening of the l5 right set screw, the l4 right set screw idled and could not be finally tightened.After replacing the screw at the right side of l4, the final tightening was completed without any problem, and the operation had been completed.The compressor was not used, and the counter torque had been used.Only the set screw that could not be finally tightened for the first time and the screw that was replaced were scheduled to be returned.The set screw behaved like idling inside when a torque that should break off the set screw by right was applied.The screw was replaced and the new one has been broken off as usual with the same driver, so there was no problem with the set screwdriver.The products were in contact with patient and has been confirmed that there are no infectious diseases.There was a possibility that the screw head or tab became widened because the set screw idled and could not be finally tightened, and when the screw was replaced with a substitute one, the final tightening could be performed as usual.There was a delay of less than 60 min in overall procedure time.There was no in-patient hospitalization or prolongation of existing hospitalization necessary.There were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.

Manufacturer Narrative

H3: product analysis: part # 6430530; lot # 0785191w.Visual and optical inspection confirmed the threads of the screw have been damaged.The threads have severe flank damage.It appears the screw was misaligned and cross threaded causing the damage to the set screw threads.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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12025890
• MDR Text Key: 258717951
• Report Number: 1030489-2021-00806
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6430530
• Device Catalogue Number: 6430530
• Device Lot Number: 0785191W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female