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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT

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MEDOS INTERNATIONAL SàRL CH UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problems Unspecified Infection (1930); Spinal Column Injury (2081)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown biomaterial - cement/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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: barbagallo g. , et al (2017) restoration of thoracolumbar spine stability and alignment in elderly patients using minimally invasive spine surgery (miss). A safe and feasible option in degenerative and traumatic spine diseases, acta neurochirurgica supplement 124 , pages 69-74 (italy) doi 10. 1007/978-3-319-39546-3_11. This study aims to analyse the prospectively collected clinical, functional, and radiological data of elderly patients treated with miss for degenerative and traumatic thoracolumbar pathologies. A total of 45 patients (17 males and 28 females) with a mean age of 73 years (range 65¿89), suffering from degenerative spondylolisthesis (15), lumbar canal stenosis with instability and or de novo scoliosis (6), and traumatic osteoporotic vertebral fractures (24) were prospectively enrolled. In 21 patients a miss pedicle-screw fixation with mini-open transforaminal lumbar interbody fusion (m-open tlif) was performed. Of the remaining 24 patients treated with miss, 18 underwent percutaneous pedicle-screw fixation (ppsf) with or without vertebral body cement augmentation (confidence spinal cement; depuy spine,) and 6 underwent vertebroplasty or kyphoplasty. The viper percutaneous pedicle-screw fixation system with fenestrated screws (depuy spine raynham, us) or the illico percutaneous fixation system (alphatec spine carlsbad, us, us) with expandable screws (osseoscrew; alphatec spine carlsbad, us) was used. Follow-up ranged from 6 to 59 months, with a mean of 28 months. The following complications were reported as follows: 2 the 45 patients developed the following postoperative complications: a case of a (b)(6)-year-old woman for surgical treatment of l2 burst fracture, previously treated elsewhere with percutaneous cement injection. X-rays performed 3 weeks after the procedure documented the pull-out of l3 screws. Replacement and augmentation of the l3 screws was performed, together with caudal extension of instrumentation. Spondylodiscitis. This report is for an unknown depuy spine confidence spinal cement. This is report 2 of 3 for (b)(4).
 
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Brand NameUNKNOWN BIOMATERIAL - CEMENT
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key9962969
MDR Text Key196568954
Report Number1526439-2020-00855
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/15/2020 Patient Sequence Number: 1
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