MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 6958734PT

Device Problem Malposition of Device (2616)

Patient Problem Nerve Damage (1979)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

A2: age - average age was 36 ± 13.4 years (range, 6-75 years) a3: sex - 33 male and 217 female (total of 250 patients).B3.Please note that this date is based off of the date that the article was published as the event dates were not provided in the published literature.H3: 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.Citation: sharon ka po.Tam, paolo a.Bolognese, roger w.Kula, andrew brodbelt, mansoor foroughi, marat avshalumov, denmark mugutso and ilene ruhoy.Safety analysis and complications of condylar screws in a single-surgeon series of 250 occipitocervical fusions.A retrospective study.Acta neurochirurgica (2022).164:903¿911.Doi.Org/10.1007/s00701-021-05039-z.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

Citation: sharon ka po.Tam, paolo a.Bolognese, roger w.Kula, andrew brodbelt, mansoor foroughi, marat avshalumov, denmark mugutso and ilene ruhoy.Safety analysis and complications of condylar screws in a single-surgeon series of 250 occipitocervical fusions.A retrospective study.Acta neurochirurgica (2022).164:903¿911.Doi.Org/10.1007/s00701-021-05039-z.Event summary: a retrospective safety and complication-based analysis of occipitocervical fusion via condylar screws fixation was performed.This study aims to evaluate the safety profile and complications of condylar screw fixation for occipitocervical fusion. a total of 250 patients underwent occipitocervical fusions using 500 condylar screws between september 2012 and september 2018. two hundred seventeen patients were females.The mean age was 36 ± 13.4 sd, ranging from 6 to 75.23 patients were below 18 years of age (ranging 6 to 17). forty-four cases were revision surgeries from a former barplate configuration.Indications for revision operations included painful profile, metal fatigue, or bar-plate breakdown, alone or in combination.One hundred eighty patients (72%) had a formal diagnosis or clinical evidence. of a connective tissue disorder.One hundred twenty-three patients (49.2%) had a suboccipital craniectomy to address chiari i malformation as a comorbidity. hypoplastic condyles were identified in 91 out of the 250 patients. five cases had large suboccipital craniectomies extending up to the transverse sinuses and laterally to the sigmoid sinuses. the occipital condyles and c1 were congenitally fused in two cases, and a single screw was inserted through these conjoined bony elements. no bmp-2 associated complication was observed.Reported events: the hypoglossal injury was documented at the beginning of the series.Out of the 500 screw insertion in our series, only two complications were directly caused by condylar screws.The case involved patients with hypoplastic condyles and thin supraocciputs.  1.In one case, a condylar screw encroached the hypoglossal nerve.The injury was caused by the screw impinging into the condylar canal. a corrective surgery was performed promptly by screw repositioning through a new pass.A near complete recovery was observed at 6 months following the corrective operation.2.The second injury was attributed to hand drilling, the hypoglossal was involved during hand drilling.The neuromonitoring promptly warned the surgeon, who redirected the drilling and the new screw trajectory.The postoperative defcit was moderate and the patient experienced a full recovery by the 6th postoperative month.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 16858389
• MDR Text Key: 314446653
• Report Number: 1030489-2023-00325
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994356727
• UDI-Public: 00613994356727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6958734PT
• Device Catalogue Number: 6958734PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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): Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female