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 Problems Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/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.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: kovari, v.Z.Et al (2020), comparison of single-level open and minimally invasive transforaminal lumbar interbody fusions presenting a learning curve, biomed research international, vol.2020, article id 3798537, pages 1-8 (hungary).The aim of this retrospective, nonrandomized study is to evaluate the possible differences and/or similarities between single-level o-tlif and mi-tlif, while mi-tlif cases were compared to display a learning curve.Between march 1, 2013 to march 31, 2018, a total of 58 patients (20 male and 38 female) were included in the study.Surgery was performed using viper 2 (depuy synthes spine, raynham, ma, usa) or a competitor's device in mi-tlif group (27 patients).While expedium, leopard and a competitor's device were used in o-tlif group (31 patients).Only 39 patients (27 mi-tlif and 31 o-tlif) were available for odi and vas comparison.The mean follow-up period was unknown.The following complications were reported as follows: 2 patients had surgical site infection (ssi) in o-tlif group.There were 4 cases of incidental durotomies in o-tlif group and 2 in mi-tlif group.All were repaired intraoperatively with no harmful outcome.1 patient had new motor deficit in the mi-tlif group which was a mild quadriceps femoris muscle weakness (4-/5) and improved to 5/5.1 patient had sensory deficit in the mi-tlif group, which was a minimal hypoesthesia in the l4 and l5 dermatomes, and 1 patient in the o-tlif group.This report is for an unknown depuy spine screw/rod constructs.This is report 1 of 3 for (b)(4).

• 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: 10479857
• MDR Text Key: 205297989
• Report Number: 1526439-2020-01590
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/07/2020
• 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