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 Problems Tissue Damage (2104); Injury (2348)

Event Type  Injury  

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 july to september 2003.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: mizuno, k.Et al (2005), intraoperative insertion torque of lumbar pedicle screw and postoperative radiographic evaluation: short-term observation, journal of orthopaedic science, vol.10 (2), pages 137-144 (japan).The aim of this study is to analyzed the factors that affect insertion torque use with a custom-made torquemeter driver in vivo.Between july to september 2003, a total of 23 patients (5 male and 18 female) with an average age of 68 years (range 49-86 years) underwent lumbar pedicle screw fixation.Surgery was performed using moss miami system (depuy spine, raynham, ma, usa) in 8 patients (10-disc levels).Follow-up was unknown.The following complications were reported as follows: 17 screws showed "cortex cutting" (screw threads cut into the anterior cortex of the vertebral body).In the moss miami group, one-disc level with radiolucent zones was observed, and one level with motion of more than 5° and with a radiolucent zone was seen; there were two of eight-disc levels that showed ¿3-month instability.¿ this report is for an unknown moss-miami.This report is for one unknown mono/polyaxial screws.This is report 3 of 8 for (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: 9494704
• MDR Text Key: 188643374
• Report Number: 1526439-2019-52724
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• 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