MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown bone cement/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: kim.C.H.Et al.(2021), efficacy of antibiotic-loaded cement augmentation for correcting low grade pedicle screw loosening, korean journal of neurotrauma, vol.17(1), pages 41-47 (south korea).This study aimed to assess the results of percutaneous fluoroscopy-guided antibiotic-loaded cement augmentation for the correction of clinically relevant screw loosening, a common challenge in the wide usage of pedicle screw fixation.Between june 2016 and july 2018, 10 patients who subsequently experienced symptomatic low-grade pedicle screw loosening underwent percutaneous cement augmentation.There were 4 males and 6 females with a mean patient age were 66.9 years (range, 56¿78 years), and the mean follow-up period was 8.8 months (range, 6¿12 months).The implant used was an antibiotic-loaded bone cement consists of 2 components-a powder and a-that were mixed before use (cmw-g; depuy synthes, raynham, ma, usa).The following complications were reported as follows: case 2: a (b)(6) year-old male patient had implant-related obscurity of the fluoroscopic landmarks, and cement filling was not successful into the halo.He was treated with percutaneous screw re-implantation via a different trajectory in the end.This report is for an unknown synthes bone cement.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12558252
• MDR Text Key: 274336774
• Report Number: 1526439-2021-02092
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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 Age: 67 YR