MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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 screw/rod construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: kasukawa, y.Et al (2015), short-term results of transforaminal lumbar interbody fusion using pedicle screw with cortical bone trajectory compared with conventional trajectory, asian spine journal, vol.9 (3), pages 440¿448 ((b)(6)).The aim of this retrospective case-control study is to evaluate clinical and radiological results of transforaminal lumbar interbody fusion (tlif) performed with cortical bone trajectory (cbt) pedicle screw insertion with those of tlif using ¿conventional¿ or percutaneous pedicle screw insertion.Between april 2011 to february 2013, a total of 26 patients (11 male and 15 female) with a mean age of 67 years (range, 34¿80 years) underwent tlif.These patients were grouped according to the methods performed.10 patients underwent tlif with pedicle screw insertion by conventional minimally invasive methods via the wiltse approach (m-tlif group) using devex cage (depuy spine, raynham, ma, usa) and expedium spine system (depuy spine).6 patients underwent tlif with percutaneous pedicle screw insertion (p-tlif group) using viper mis spine system (depuy spine).Lastly, the remaining 10 patients underwent tlif with pedicle screw insertion with cbt (cbt-tlif) using a competitor device.The mean final follow-up for m-tlif, p-tlif, and cbt-tlif were 15.7±6.0, 11.0±7.7, and 11.4±3.6 months, respectively.The following complications were reported as follows: m-tlif group: 2/12 levels in 10 patients had delayed bone union at final follow-up.7 screws were in contact with the medial wall of the affected pedicle.P-tlif group: 1 screw was in contact with the medial wall of the affected pedicle.2 screws were in contact with the lateral wall of the pedicle.This report is for an unknown depuy spine screw/rod constructs.This is report 1 of 4 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 10843422
• MDR Text Key: 218505422
• Report Number: 1526439-2020-02196
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: 10/19/2020
• 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