MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kleck cj, et al.(2018).One-step minimally invasive pedicle screw instrumentation using o-arm and stealth navigation, clin spine surg, volume 31, page 197-202, (usa).This study describes the new techniques and evaluates safety in a series of patients who have undergone placement of pedicle screws with our minimally invasive technique.A total of 35 adult patients (187 screws) who underwent thoracolumbar spine fusion using 2- or 1-step minimally invasive pedicle screw placement were included in the study.There were 22 males and 13 females with an average age of 49 years old (range 28-67 years).Pedicle screws implanted to the patients include unknown depuy spine expedium pedicle screws.Follow-up ranged from 1 to 20 months complications were reported as follows: 2 grade 3 screws were found to be breached inferior at the time of the second intraoperative o-arm spin, and in both cases the screws were repositioned without neurological sequelae.1 screw was found to protrude too far anteriorly (but fully contained within the pedicle) at s1 and was replaced with a shorter screw.1 patient had a nonunion.At 1-year postoperative, the patient was having continued pain and a ct scan verified pseudoarthrosis at the l5¿s1 level.The patient underwent a revision posterior fusion procedure.1 male patient was found to have a superficial deep vein thrombosis at 2 weeks postoperative.He had a positive family history of deep vein thrombosis.He was treated without further issue.Depuy spine products: this report is for the unknown depuy spine expedium pedicle screws.It captures the reported male patient with superficial deep vein thrombosis at 2 weeks postoperative.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9566200
• MDR Text Key: 189439193
• Report Number: 1526439-2020-00303
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention