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

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 11/12/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: 510k: this report is for an unknown biomaterial - cement: confidence.Device available for evaluation: 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 wu, s.C.H., luo, a.J., and liao, j.C.(2022) cement augmentation for treatment of high to mid-thoracic osteoporotic compression fractures, high-viscosity cement percutaneous vertebroplasty versus balloon kyphoplasty, scientific reports, vol.12 (19404), pages 1-8 (taiwan).The aim of this study is to identify the different outcomes between hvc vp and lvc bkp used to repair high (t4¿6) and mid (t7¿9)-thoracic vcfs.Between january 2015 to december 2020, a total of 114 patients with painful collapsed single-level vertebrae at high to mid-thoracic level who underwent vertebral body augmentation were enrolled.According to their surgical procedures, 72 patients were treated with high-viscosity cement (hvc) vertebroplasty (vp) versus 42 with low-viscosity cement (lvc) balloon kyphoplasty (bkp).In the hvc vp group (57 female and 15 male), with a mean age of 74.61 ± 13.41 years.In the lvc bkp group (38 female and 4 male) with a mean age of 77.57 ± 7.14 years.A falls accident was the cause for 44.4% of the compression fractures in the hvc vp group and 61.9% in the lvc bkp group; the other patients appeared to have sustained vertebral compression fractures for no apparent reason.For all patients treated with hvc vp (confidence spinal cement, depuy spine, uas) or lvc bkp with a competitor device.The following complications were reported as follows: hvc vp group: (n=26) patients had cement leakage (n=6) patients had an incidence of adjacent fractures following cement augmentation an unknown number of patients experienced recurrent vertebral height loss following cement augmentation.This report is for an unk - biomaterial - cement: confidence.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16186411
• MDR Text Key: 308925165
• Report Number: 1526439-2023-00076
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 12/20/2022
• 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