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 Injury (2348)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

A total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments.Exact date of event is unknown; july 06, 2018 is the date the literature article was published.This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number 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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: scarone, p.Et al.(2018), use of the airo mobile intraoperative ct system versus the o-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, journal of neurosurgical spine, vol.29, pages 397-406 (switzerland).The primary objective of this study was to compare the in vivo accuracy of these 2 navigation-enabling technologies during pedicular screw positioning at the thoracic and lumbar levels during percutaneous and open surgeries.Determining the rate of intraoperative screw repositioning, postoperative clinical results, surgical time, and radiation exposure were secondary objectives.Between january 2013 and november 2015, a total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments.The following complications were reported as follows: (in this study, heary grade 1¿3 screws were considered correctly placed, and heary grade 4 and 5 screws were considered misplaced.) 6 screws were heary grade 4.7 screws were repositioned intraoperatively.A (b)(6)-year old female patient experienced a partial motor deficit (m2) in her right foot after medial repositioning of an l5 pedicle screw in open surgery that needed a new intervention on postoperative day 1.The screw was classified as heary grade 4 on the final intraoperative ct image that was acquired before repositioning.The new screw position was not verified by an intraoperative scan.This report is for an unknown mono/polyaxial screws.This is report 2 of 7 for pc-(b)(4) additional devices are captured on related complaints pc-(b)(4) and pc-(b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 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
• MDR Report Key: 9532073
• MDR Text Key: 189177753
• Report Number: 1526439-2019-52832
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention