MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: martin-somoza f.J., escribano j.M.C., ramírez-villaescusa j.V., (2021) long-term reliability of the two-segment fusion technique in the treatment of thoracolumbar fractures using screws in the fractured vertebra, international journal of spine surgery, vol.15, no.1,pp.169¿178 (spain).This longitudinal observational retrospective study aims to evaluate the advantages of short fusion including screws at the fracture level in type a burst fractures, as few studies have evaluated the results of two segment short fusion of the fractured vertebra and its long-term evolution.Between 2000 and 2015, patients with unstable types a2, a3, and a4 vertebral burst fractures located in the thoracolumbar region (t11¿l2) and using short fusion with screws placed on the fractured vertebra were included in the study.A total of 64 patients with burst thoracolumbar fractures (t11¿l2) fulfilled the inclusion criteria, and 10 patients were excluded from the study.From a total of 54 patients, 35 were male, and 19 were female, with a mean age of 44.07 years (sd 16.15).During surgery, the vertebrae above and below the fractured one were instrumented with side-connecting screws (scs) (colorado2, medtronic sofamor/danek, memphis, tennessee), in 38 patients, or top-loading screws (tls) (legacy medtronic and expedium, de puy synthes, raynham, massachusetts), in 16 patients, being parallel to the end plate.The mean of follow-up period was 8.03 years (sd 3.75).The following complications were reported: three patients passed away.(included in the patients who were excluded from the study).Surgical complications: one infection of surgical wounds.Three needed blood transfusion due to postsurgical severe anemia.Loss of kyphosis correction during the follow-up period was observed.A long-term progression of vk, rk, and tlk is observed (tlk 228, rk 168, and vk 138).Vk indicates vertebral kyphosis; rk, regional kyphosis; tlk, thoracolumbar kyphosis; ct, computed tomography 25-year-old man with an l1 a3 burst fracture and preoperative t12¿l2 kyphosis of 23 degrees.Ct indicates computed tomography; tlk, thoracolumbar kyphosis postoperatively.X-ray image at the end of follow-up (8 years after surgery).This report is for unknown depuy spine top-loading screws expedium.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for unknown expedium screws/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.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 14698081
• MDR Text Key: 294046717
• Report Number: 1526439-2022-00853
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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: 05/17/2022
• 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