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

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown confidence 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: griffoni, c.Et al (2020), percutaneous vertebroplasty and balloon kyphoplasty in the treatment of osteoporotic vertebral fractures: a prospective randomized comparison, european spine journal, vol.29 (xx), pages 1614¿1620 (italy).The aim of this multicenter, prospective and randomized trials is to compare the efficacy of bkp and pvp in terms of pain control, fracture reduction and incidence of new fractures.Between 2011 to 2015, a total of 113 patients were included in the study.64 patients (11 male and 53 female; mean age 72 ± 6.4 years) were randomized for percutaneous vertebroplasty (pvp group) and 49 patients (9 male and 40 female; mean age of 75 ± 8.6 years) for balloon kyphoplasty (bkp group).Pvp was performed with confidence-depuy spine pmma, and bkp was performed using a competitor device.The mean follow-up period was unknown.The following complications were reported as follows: 3 patients had cement leakage.15 patients had new fractures and reintervention after vertebroplasty.8 patients (unknown group) had only one fracture, while the other patients had multiple fractures.3 of them were admitted and surgically treated twice during the follow-up period.During follow-up, we registered a total of forty new fractures in 113 patients (3.5%), and among these, twelve have fractures on the level adjacent to the treated level.11 cases of adjacent fractures occurred in the pvp group.This report is for an unknown depuy spine confidence cement.It captures reported new fractures, adjacent fractures and underwent reintervention.A copy of the literature article is being submitted with this medwatch.This is report 2 of 2 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• 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: 12468562
• MDR Text Key: 271369364
• Report Number: 1526439-2021-01997
• Device Sequence Number: 1
• Product Code: NDN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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: 08/17/2021
• 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 Outcome(s): Required Intervention