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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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.

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2012 to february 2014.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

This report is being filed after the review of the following journal article: innocenzi, g.Et al (2017), does navigation improve pedicle screw placement accuracy? comparison between navigated and non-navigated percutaneous and open fixations, in: visocchi m., mehdorn h.M., katayama y., von wild k.R.H.(eds) trends in reconstructive neurosurgery.Acta neurochirurgica supplement, vol.124, pages 289-295, doi 10.1007/978-3-319-39546-3_42 (italy).The aim of this study is to compare the efficacy and reliability of an open free-hand technique, an open navigated technique (brainlab® system), a percutaneous ct-based navigation technique, and a percutaneous fluoroscopy-guided technique.Between january 2012 to february 2014, a total of 203 patients (88 male and 115 female) underwent thoracic and lumbar fusion with percutaneous techniques.Surgery was performed using viper 2 system and open pedicle screw (expedium 5.5 system, depuy spine, raynham, ma).Follow-up period is unknown.The following complications were reported as follows: direction of breaches in lumbar vertebrae according to screws placement: 10 screws in group p were lateral axial/coronal; 6 screws in group pn and 3 screws in group p that were grade 1; 4 screws in group on, 2 screws in group o, 1 screw in group pn, and 1 screw in group p were grade 2; 1 screw in group on, 2 screws in group o and 2 screws in group pn were grade 3.1 screw in group on, 8 screws in group pn and 7 screws in group p were medial axial/coronal; 5 screws in group pn and 3 screws in group p were grade 1; 2 screws in group pn and 8 screws in group p were grade 2.4 screws in group on, 11 screws in group o, 8 screws in group pn and 10 screws in group p were anterior axial; 1 screw in group o and 4 screws in group p were grade 1; 2 screws in group o and 6 screws in group p were grade 2.5 screws in group on and 2 screws in group p were caudal sagittal/coronal; 1 screw in group p was grade 1.1 screw in group on and 1 screw in group p were cranial sagittal/coronal.1 patient in group on and 1 patient in group o had transient neurological deficit.2 patients in group o had superficial wound infection treated with debridement and antibiotics.2 patients in group on had superficial wound infection treated with antibiotics.1 patient in group on had deep wound infection.1 patient in group on, 2 patients in group o and 1 patient in group p had prolongation of stabilization.Patients who underwent replacement of implant because of pain were: 1 patient in group pn who had l4 medial displacement grade 3 after 1 week.1 patient in group p who had intraoperative d12 medial displacement grade 3.1 patient in group p who had l5 medial displacement grade 3 after 1 week.1 patient in group p who had l5 medial displacement grade 3 after 2 months.2 patients in group p who had l5 medial displacement grade 3 and l4 medial displacement grade 3 after 2 days.This report is for an unknown depuy spine viper 2 and unknown depuy spine expedium.This report is for one unknown mono/polyaxial screw.This is report 7 of 10 for (b)(4).This report is linked to (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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9538695
• MDR Text Key: 184373539
• Report Number: 1526439-2020-00027
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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