MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/ polyaxial screws/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: wang, m.Y.(2013), improvement of sagittal balance and lumbar lordosis following less invasive adult spinal deformity surgery with expandable cages and percutaneous instrumentation, journal of neurosurgery: spine, vol.18 (xx), pages 4-12 (usa).The aim of this study is to describe the evolution of an mis method for treating asd with attention to sagittal correction.During an 18-month period, a total of 25 patients (8 male and 17 female; mean age of 72 years) were treated surgically.Surgery was performed using viper (depuy spine) together with competitor devices.The minimum follow-up period after surgery was 12 months.The following complications were reported as follows: 3 patients had worsening of coronal balance due to straightening of the major curve without addressing the fractional curve adequately.In 2 of these patient¿s coronal balance worsened from 1 cm to 3 cm, and in another patient it worsened from 2 cm to 3 cm (fig.5).1 patient experienced neurological worsening which involved new dorsiflexor weakness of the foot.In 1 patient with preoperative nerve root pain, there is no resolution of leg pain.1 patient had a prolonged hospitalization course due to severe constipation.In 3/25 patients (3 of 52 treated levels) in which fusion could not be verified, this occurred at the thoracolumbar junction where no interbody fusion was performed.In 1 case there was some evidence of screw loosening and in the other 2 levels, there was a paucity of bony growth in the posterolateral or interlaminar space.However, these patients did not experience any local symptoms of pseudarthrosis as of the last follow-up.2 patients had a medial l-5 screw breach.In 1 case the screw was removed 2 weeks after the index surgery due to foot weakness.In the other case, the patient only had numbness and the screw was removed after confirmation of solid bony fusion 9 months after surgery.1 patient had an asymptomatic grade ii screw breach at t-10.1 patient had an early screw pullout at s-1 and the screw was removed 1 year later after confirmation of successful l5¿s1 fusion.A (b)(6) year-old woman who did not suffer permanent myocardial ischemia had acute coronary syndrome.This report is for an unknown depuy spine viper constructs and unknown depuy spine viper mono/ polyaxial screws.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12454415
• MDR Text Key: 271298543
• Report Number: 1526439-2021-01932
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 11/02/2021
• 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